Metal alloys for metal devices

ABSTRACT

A medical device and a method and process for at least partially forming a medical device, which medical device has improved physical properties.

The present invention is a continuation of U.S. patent application Ser.No. 17/969,937 filed Oct. 20, 2022, which in turn is a continuation ofU.S. patent application Ser. No. 17/512,174 filed Oct. 27, 2021 (nowU.S. Pat. No. 11,504,451), which in turn in a divisional of U.S. patentapplication Ser. No. 15/320,830 filed Dec. 21, 2016 (now U.S. Pat. No.11,266,767) which in turn claims priority on PCT Application Serial No.PCT/US2015/029213 filed May 5, 2015, which in turn claims priority onU.S. Provisional Application Ser. No. 62/016,189 filed Jun. 24, 2014,which are all incorporated herein by reference.

The invention relates generally to medical devices, and particularly toa medical device that is at least partially formed of a novel molybdenumand rhenium metal alloy, and more particularly to dental implant,implant or prosthetic device that is at least partially formed of anovel molybdenum and rhenium metal alloy.

SUMMARY OF THE INVENTION

The present invention is generally directed to a medical device that isat least partially made of a novel metal alloy having improvedproperties as compared to past medical devices. The novel metal alloyused to at least partially form the medical device improves one or moreproperties (e.g., strength, durability, hardness, biostability,bendability, coefficient of friction, radial strength, flexibility,tensile strength, tensile elongation, longitudinal lengthening,stress-strain properties, improved recoil properties, radiopacity, heatsensitivity, biocompatibility, etc.) of such medical device. These oneor more improved physical properties of the novel metal alloy can beachieved in the medical device without having to increase the bulk,volume and/or weight of the medical device. In some instances, theseimproved physical properties can be obtained even when the volume, bulkand/or weight of the medical device is reduced as compared to medicaldevices that are at least partially formed from traditional stainlesssteel or cobalt and chromium alloy materials.

The novel metal alloy that is used to at least partially form themedical device can thus 1) increase the radiopacity of the medicaldevice, 2) increase the radial strength of the medical device, 3)increase the yield strength and/or ultimate tensile strength of themedical device, 4) improve the stress-strain properties of the medicaldevice, 5) improve the crimping and/or expansion properties of themedical device, 6) improve the bendability and/or flexibility of themedical device, 7) improve the strength and/or durability of the medicaldevice, 8) increase the hardness of the medical device, 9) improve thelongitudinal lengthening properties of the medical device, 10) improvethe recoil properties of the medical device, 11) improve the frictioncoefficient of the medical device, 12) improve the heat sensitivityproperties of the medical device, 13) improve the biostability and/orbiocompatibility properties of the medical device, and/or 14) enablesmaller, thinner and/or lighter weight medical devices to be made.

The medical device generally includes one or more materials that impartthe desired properties to the medical device so as to withstand themanufacturing processes that are needed to produce the medical device.These manufacturing processes can include, but are not limited to, lasercutting, etching, crimping, annealing, drawing, pilgering,electroplating, electro-polishing, chemical polishing, cleaning,pickling, ion beam deposition or implantation, sputter coating, vacuumdeposition, etc.

In another non-limiting aspect of the present invention, a medicaldevice that can include the novel alloy is an orthopedic device, PFO(patent foramen ovale) device, stent, valve, spinal implant, vascularimplant, graft, guide wire, sheath, stent catheter, electrophysiologycatheter, hypotube, catheter, staple, cutting device, any type ofimplant, pacemaker, dental implant, bone implant, prosthetic implant ordevice to repair, replace and/or support a bone (e.g., acromion, atlas,axis, calcaneus, carpus, clavicle, coccyx, epicondyle, epitrochlea,femur, fibula, frontal bone, greater trochanter, humerus, ilium,ischium, mandible, maxilla, metacarpus, metatarsus, occipital bone,olecranon, parietal bone, patella, phalanx, radius, ribs, sacrum,scapula, sternum, talus, tarsus, temporal bone, tibia, ulna, zygomaticbone, etc.) and/or cartilage, nail, rod, screw, post, cage, plate,pedicle screw, cap, hinge, joint system, wire, anchor, spacer, shaft,spinal implant, anchor, disk, ball, tension band, locking connector, orother structural assembly that is used in a body to support a structure,mount a structure and/or repair a structure in a body such as, but notlimited to, a human body. In one non-limiting application, the medicaldevice is a dental implant dental filling, dental tooth cap, dentalbridge, braces for teeth, dental teeth cleaning equipment, and/or anyother medical device used in the dental or orthodontia field. In anothernon-limiting application, the medical device is a stent. In stillanother non-limiting application, the medical device is a spinalimplant. In yet another non-limiting application, the medical device isa prosthetic device. Although the present invention will be describedwith particular reference to medical devices, it will be appreciatedthat the novel alloy can be used in other components that are subjectedto stresses that can lead to cracking and fatigue failure (e.g.,automotive parts, springs, aerospace parts, industrial machinery, etc.).

In still another non-limiting aspect of the present invention, carbonnanotubes (CNT) can optionally be incorporated into a metal material toform the novel alloy. Although the novel alloy is described as includingone or more metals and/or metal oxides, it can be appreciated that someor all of the metal and/or metal oxide in the novel alloy can besubstituted for one or more materials selected from the group ofceramics, plastics, thermoplastics, thermosets, rubbers, laminates,non-wovens, etc. The one or more metals used in the novel alloygenerally have an alloy matrix and the CNT can be optionallyincorporated within the grain structure of the alloy matrix. It isbelieved that certain portions of the CNT, when used, will cross thegrain boundary of the metal material and embed into the neighboringgrains, thus forming an additional linkage between the grains. When anovel alloy is employed in dynamic application, a cyclic stress isapplied on the alloy. At some point, at a number of cycles, the novelalloy will crack due to fatigue failure that initiates and propagatesalong the grain boundaries. It is believed that the attachment of CNTacross the grains will prevent or prolong crack propagation and fatiguefailure. Further, when the grain size is large, then the CNT getscompletely embedded into a grain. The twinning of the grains is limitedby the presence of CNT either fully embedded or partially embeddedwithin the grain structure. Additionally, the CNT offers better surfaceerosion resistance. The novel alloy that includes the CNT can be made bypowder metallurgy by adding the CNT to the metal powder or mixture ofvarious metal powders to make a multicomponent alloy. The mixture canthen be compressed under high isostatic pressure into a preform wherethe particles of the powder fuse together and thereby trap the CNT intothe matrix of the novel alloy. The preform can then be sintered underinert atmosphere or reducing atmosphere and at temperatures that willallow the metallic components to fuse and solidify. Depending on thedesired grain structure, the fused metal can then be annealed or furtherprocessed into the final shape and then annealed. At no point should thenovel alloy be heated above 300° C. without enclosing the novel alloy inan inert or reducing atmosphere and/or under vacuum. The material canalso be processed in several other conventional ways. One in particularwill be by metal injection molding or metal molding technique in whichthe metal and CNT are mixed with a binder to form a slurry. The slurryis then injected under pressure into a mold of desired shape. The slurrysets in the mold and is then removed. The binder is then sintered off inmultiple steps, leaving behind the densified metal-CNT composite. Thenovel alloy can be heated up to 1500° C. in an inert or reducingatmosphere and/or under vacuum.

Most elemental metals and alloys have a fatigue life which limits itsuse in a dynamic application where cyclic load is applied during itsuse. The novel alloy prolongs the fatigue life of the medical device.The novel alloy is believed to have enhanced fatigue life, enhancing thebond strength between grain boundaries of the metal in the novel alloy,thus, inhibiting, preventing or prolonging the initiation andpropagation of cracking that leads to fatigue failure. For example, inan orthopedic spinal application, the spinal rod implant undergoesrepeated cycles throughout the patient's life and can potentially causethe spinal rod to crack. Titanium is commonly used in such devices;however, titanium has low fatigue resistance. The fatigue resistance canbe improved by alloying the titanium metal with CNT in the mannerdescribed above. If higher strength as well as higher fatigue resistanceis required, then the CNT can be alloyed with novel alloy to obtain suchproperties. With the addition of at least about 0.05 wt. % and up toabout 5-10 wt. %, typically at least about 0.5 wt. %, and more typicallyabout 0.5-5% wt. % of CNT to the metal material of the novel alloy, thenovel alloy can exhibit enhanced fatigue life.

In another and/or alternative non-limiting aspect of the presentinvention, the medical device is generally designed to include at leastabout 25 wt. % of the novel metal alloy (i.e., 25%, 25.01%, 25.02% . . .99.98%, 99.99%, 100% and any value or range therebetween); however, thisis not required. In one non-limiting embodiment of the invention, themedical device includes at least about 40 wt. % of the novel metalalloy. In another and/or alternative non-limiting embodiment of theinvention, the medical device includes at least about 50 wt. % of thenovel metal alloy. In still another and/or alternative non-limitingembodiment of the invention, the medical device includes at least about60 wt. % of the novel metal alloy. In yet another and/or alternativenon-limiting embodiment of the invention, the medical device includes atleast about 70 wt. % of the novel metal alloy. In still yet anotherand/or alternative non-limiting embodiment of the invention, the medicaldevice includes at least about 85 wt. % of the novel metal alloy. In afurther and/or alternative non-limiting embodiment of the invention, themedical device includes at least about 90 wt. % of the novel metalalloy. In still a further and/or alternative non-limiting embodiment ofthe invention, the medical device includes at least about 95 wt. % ofthe novel metal alloy. In yet a further and/or alternative non-limitingembodiment of the invention, the medical device includes about 100 wt. %of the novel metal alloy.

In still another and/or alternative non-limiting aspect of the presentinvention, the novel metal alloy that is used to form all or part of themedical device 1) is not clad, metal sprayed, plated and/or formed(e.g., cold worked, hot worked, etc.) onto another metal, or 2) does nothave another metal or metal alloy metal sprayed, plated, clad and/orformed onto the novel metal alloy. It will be appreciated that in someapplications, the novel metal alloy of the present invention may beclad, metal sprayed, plated and/or formed onto another metal, or anothermetal or metal alloy may be plated, metal sprayed, clad and/or formedonto the novel metal alloy when forming all or a portion of a medicaldevice.

In yet another and/or alternative non-limiting aspect of the presentinvention, the novel metal alloy can be used to form a coating on aportion of all of a medical device. For example, the metal alloy can beused as a coating on articulation points of artificial joints. Such acoating can provide the benefit of better wear, scratch resistance,and/or elimination of leaching harmful metallic ions (i.e., Co, Cr,etc.) from the articulating surfaces when the undergo fretting (i.e.,scratching during relative motion). As can be appreciated, the metalalloy can have other or additional advantages. As can also beappreciated, the metal alloy can be coated on other or additional typesof medical devices. The coating thickness of the metal alloy isnon-limiting. In one non-limiting example, there is provided a medicaldevice in the form of a clad rod wherein in the core of the rod isformed of a metal (e.g., iron, CoCr alloy, titanium alloy, SS steel,MoHfC, MoY2O3, MoCs2O, MoW, MoTa, MoZrO2, MoRe alloy, NiCoCrMo alloy,NiCrMoTi alloy, NiCrCuNb alloy, TiAlV alloy, etc.) or ceramic orcomposite material, and the other layer of the clad rod is formed of themetal alloy. The core and the other layer of the rod can each form50-99% of the overall cross section of the rod. As can also beappreciated, the metal alloy can form the outer layer of other oradditional types of medical devices. The coating can be used to create ahard surface on the medical device (e.g., MoRe article, etc.) atspecific locations as well as all over the surface. The base hardness ofmetal alloy (e.g., MoRe, etc.) can be as low as 300 Vickers and/or ashigh as 500 Vickers. However, at high harness the properties may not bedesirable. In instances where the properties of fully annealed softermetal alloy is desired, but only the surface requires to be hardened asin this invention, the present invention includes a method that canprovide benefits of both a softer metal alloy with harder outer surfaceor shell. A non-limiting example is an orthopedic screw where a softeralloy is desired for high ductility as well as ease of machinability.Simultaneously, a hard shell is desired of the finished screw. While theinner hardness can range from 250 Vickers to 550 Vickers, the outerharness can vary from 350 Vickers to 1000 Vickers when using the samealloy.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the novel metal alloy can be used to form a core of aportion or all of a medical device. For example, a medical device can bein the form of a rod. The core of the core of the rod can be formed ofthe metal alloy and then the outside of the core can then be coated withone or more other materials (e.g., another type of metal or metal alloy,polymer coating, ceramic coating, composite material coating, etc.).Such a rod can be used, for example, for orthopedic applications suchas, but not limited to, spinal rods and/or pedicle screw systems.Non-limiting benefits to using the metal alloy in the core of a medicaldevice include reducing the size of the medical device, increasing thestrength of the medical device, and/or maintaining or reducing the costof the medical device. As can be appreciated, the metal alloy can haveother or additional advantages. As can also be appreciated, the metalalloy can form the core of other or additional types of medical devices.The core size and/or thickness of the metal alloy are non-limiting. Inone non-limiting example, there is provided a medical device in the formof a clad rod wherein the core of the rod is formed of a metal alloy,and the other layer of the clad rod is formed of a metal (e.g., CoCralloy, titanium alloy, SS steel, MoHfC, MoY2O3, MoCs2O, MoW, MoTa,MoZrO2, MoRe alloy, NiCoCrMo alloy, NiCrMoTi alloy, NiCrCuNb alloy,TiAlV alloy, etc.). The core and the other layer of the rod can eachform 50-99% of the overall cross section of the rod. As can also beappreciated, the metal alloy can form the core of other or additionaltypes of medical devices.

In another and/or alternative non-limiting aspect of the presentinvention, the novel metal alloy that is used to form all or a portionof the medical device includes rhenium and molybdenum. The novel alloycan include one or more other metals such as, but not limited to,calcium, chromium, cobalt, copper, gold, hafnium, iron, lead, magnesium,nickel, niobium, osmium, platinum, rare earth metals, silver, tantalum,technetium, titanium, tungsten, vanadium, yttrium, zinc, zirconium,and/or alloys thereof. In one non-limiting formulation, the novel metalalloy includes at least about 20 wt. % rhenium, at least 20 wt. %molybdenum, the total content of the rhenium and molybdenum in the novelalloy is at least 50 wt. %, and the novel metal alloy can optionallyinclude one or more metals selected from the group of hafnium, niobium,osmium, platinum, technetium, titanium, tungsten, vanadium, andzirconium. In this non-limiting formulation, the total content of theone or more optional metals is generally up to 45 wt. %. In onenon-limiting formulation, the novel metal alloy includes 20-70 wt. %(and all values and ranges therebetween) rhenium, 20-70 wt. % (and allvalues and ranges therebetween) molybdenum, and 0.05-35 wt. % (and allvalues and ranges therebetween) of one or more metals selected from thegroup of hafnium, niobium, osmium, platinum, technetium, titanium,tungsten, vanadium, and zirconium. In another non-limiting formulation,the novel metal alloy includes 35-65 wt. % (and all values and rangestherebetween) rhenium, 35-65 wt. % (and all values and rangestherebetween) molybdenum, and 0.05-20 wt. % (and all values and rangestherebetween) of one or more metals selected from the group consistingof hafnium, niobium, osmium, platinum, technetium, titanium, tungsten,vanadium, and zirconium. In still another non-limiting formulation, thenovel metal alloy includes 40-60 wt. % (and all values and rangestherebetween) rhenium, 40-60 wt. % (and all values and rangestherebetween) molybdenum, and 0.05-20 wt. % (and all values and rangestherebetween) of one or more metals selected from the group consistingof hafnium, niobium, osmium, platinum, technetium, titanium, tungsten,vanadium, and zirconium, and/or alloys of one or more of suchcomponents. As can be appreciated, one or more additional metals can bealso included in the novel metal alloy (e.g., aluminum, antimony,barium, cadmium, calcium, chromium, cobalt, copper, gallium, germanium,gold, indium, iridium, iron, lead, magnesium, manganese, nickel, osmium,palladium, platinum, rare earth metals, rhodium, ruthenium, scandium,selenium, silicon, silver, strontium, tantalum, tellurium, tin, yttrium,and/or zinc, and/or alloys of one or more of such components). One ormore metal oxides also can optionally be included in the metal alloy(e.g., cerium oxide, lanthanum oxide, yttrium oxide, zirconium oxide,MoY2O3, MoCs2O, MoZrO2, MoLa2O3, etc.).

If one or more of these additional metals and/or metal oxides areincluded in the novel metal alloy, the total content of such additionalmetals in the novel metal alloy is about 0.005 wt. %-5 wt. % (and allvalues and ranges therebetween), typically 0.005-2 wt. % (and all valuesand ranges therebetween), more typically 0.005-1 wt. % (and all valuesand ranges therebetween), and still more typically 0.005-0.5 wt. % (andall values and ranges therebetween). When hafnium is included in thenovel metal alloy, the content of hafnium in the novel metal alloy isabout 0.01-5 wt. % (and all values and ranges therebetween), typically0.02-2 wt. % (and all values and ranges therebetween), more typically0.05-1 wt. % (and all values and ranges therebetween), and even moretypically 0.05-0.5 wt. % (and all values and ranges therebetween). Whenniobium is included in the novel metal alloy, the content of niobium inthe novel metal alloy is about 0.01-5 wt. % (and all values and rangestherebetween), typically 0.02-2 wt. % (and all values and rangestherebetween), more typically 0.05-1 wt. % (and all values and rangestherebetween), and even more typically 0.05-0.5 wt. % (and all valuesand ranges therebetween). When osmium is included in the novel metalalloy, the content of niobium in the novel metal alloy is about 0.01-5wt. % (and all values and ranges therebetween), typically 0.02-2 wt. %(and all values and ranges therebetween), more typically 0.05-1 wt. %(and all values and ranges therebetween), and even more typically0.05-0.5 wt. % (and all values and ranges therebetween). When platinumis included in the novel metal alloy, the content of platinum in thenovel metal alloy is about 0.01-5 wt. % (and all values and rangestherebetween), typically 0.02-2 wt. % (and all values and rangestherebetween), more typically 0.05-1 wt. % (and all values and rangestherebetween), and even more typically 0.05-0.5 wt. % (and all valuesand ranges therebetween). When technetium is included in the novel metalalloy, the content of technetium in the novel metal alloy is about0.01-5 wt. % (and all values and ranges therebetween), typically 0.02-2wt. % (and all values and ranges therebetween), more typically 0.05-1wt. % (and all values and ranges therebetween), and even more typically0.05-0.5 wt. % (and all values and ranges therebetween). When titaniumis included in the novel metal alloy, the content of titanium in thenovel metal alloy is about 0.01-2 wt. % (and all values and rangestherebetween), typically 0.02-1 wt. % (and all values and rangestherebetween), more typically 0.05-0.8 wt. % (and all values and rangestherebetween), and even more typically 0.05-0.5 wt. % (and all valuesand ranges therebetween). When tungsten is included in the novel metalalloy, the content of tungsten in the novel metal alloy is about 0.01-3wt. % (and all values and ranges therebetween), typically 0.02-2 wt. %(and all values and ranges therebetween), more typically 0.05-1 wt. %(and all values and ranges therebetween), and even more typically0.05-0.5 wt. % (and all values and ranges therebetween). When vanadiumis included in the novel metal alloy, the content of vanadium in thenovel metal alloy is about 0.01-wt. % (and all values and rangestherebetween), typically 0.02-2 wt. % (and all values and rangestherebetween), more typically 0.05-1 wt. % (and all values and rangestherebetween), and even more typically 0.05-0.5 wt. % (and all valuesand ranges therebetween). When zirconium is included in the novel metalalloy, the content of zirconium in the novel metal alloy is about0.01-wt. % (and all values and ranges therebetween), typically 0.02-2wt. % (and all values and ranges therebetween), more typically 0.05-1wt. % (and all values and ranges therebetween), and even more typically0.05-0.5 wt. % (and all values and ranges therebetween).

When titanium is optionally included in the novel metal alloy, thetitanium content is typically less than about 1 wt. %, more typicallyless than about 0.6 wt. %, even more typically about 0.05-0.5 wt. %,still even more typically about 0.1-0.5 wt. %. As can be appreciated,other wt. % percentages of the titanium content of the novel metal alloycan be used. When zirconium is optionally included in the novel metalalloy, the zirconium content is typically less than about 0.5 wt. %,more typically less than about 0.3 wt. %, even more typically about0.01-0.25 wt. %, still even more typically about 0.05-0.25 wt. %. As canbe appreciated, other weight percentages of the zirconium content of thenovel metal alloy can be used. When titanium and zirconium are includedin the novel metal alloy, the weight ratio of titanium to zirconium isabout 1-10:1, typically about 1.5-5:1, and more typically about1.75-2.5:1. When yttrium is optionally included in the novel metalalloy, the yttrium content is typically less than about 0.3 wt. %, moretypically less than about wt. %, and even more typically about 0.01-0.1wt. %. As can be appreciated, other weight percentages of the yttriumcontent of the novel metal alloy can be used. The inclusion of titanium,yttrium and/or zirconium in the novel metal alloy can be used to reducethe amount of oxygen trapped in the solid solution in the novel metalalloy. The reduction of trapped oxygen enables the formation of asmaller grain size in the novel metal alloy and/or an increase in theductility of the novel metal alloy. The reduction of trapped oxygen inthe novel metal alloy can also increase the yield strength of the novelmetal alloy as compared to alloys of only molybdenum and rhenium (i.e.,2-10% increase). The inclusion of titanium, yttrium and/or zirconium inthe novel metal alloy is also believed to cause a reduction in thetrapped free carbon in the novel metal alloy. The inclusion of titanium,yttrium and/or zirconium in the novel metal alloy is believed to formcarbides with the free carbon in the novel metal alloy. This carbideformation is also believed to improve the ductility of the novel metalalloy and to also reduce the incidence of cracking during the forming ofthe metal alloy into a medical device (e.g., stent, dental implant, boneimplant, prosthetic implant, orthopedic device, etc.). As such, thenovel metal alloy can exhibit increased tensile elongation as comparedto alloys of only molybdenum and rhenium (i.e., 1-8% increase). Theinclusion of titanium, yttrium and/or zirconium in the novel metal alloyis also believed to cause a reduction in the trapped free nitrogen inthe novel metal alloy. The inclusion of titanium, yttrium and/orzirconium in the novel metal alloy is believed to form carbo-nitrideswith the free carbon and free nitrogen in the novel metal alloy. Thiscarbo-nitride formation is also believed to improve the ductility of thenovel metal alloy and to also reduce the incidence of cracking duringthe forming of the metal alloy into a medical device (e.g., stent,dental implant, bone implant, prosthetic implant, orthopedic device,etc.). As such, the novel metal alloy can exhibit increased tensileelongation as compared to alloys of only molybdenum and rhenium (i.e.,1-8% increase). The reduction in the amount of free carbon, oxygenand/or nitrogen in the novel metal alloy is also believed to increasethe density of the novel metal alloy (i.e., 1-5% increase). Theformation of carbides, carbo-nitrides, and/or oxides in the novel metalalloy can result in the formation of dispersed second phase particles inthe novel metal alloy, thereby facilitating in the formation of smallgrain sizes in the metal alloy.

In still another and/or alternative non-limiting aspect of the presentinvention, the novel metal alloy that is used to form all or a portionof the medical device is a novel metal alloy that includes at leastabout 90 wt. % molybdenum and rhenium of one or more metals selectedfrom the group of hafnium, niobium, osmium, platinum, technetium,titanium, tungsten, vanadium, and zirconium. In one non-limitingcomposition, the content of molybdenum and rhenium in the novel metalalloy is at least about 95 wt. % of one or more metals selected from thegroup consisting of hafnium, niobium, osmium, platinum, technetium,titanium, tungsten, vanadium, and zirconium. In another and/oralternative non-limiting composition, the content of molybdenum andrhenium in the novel metal alloy is at least about 97 wt. % of one ormore metals selected from the group consisting of hafnium, niobium,osmium, platinum, technetium, titanium, tungsten, vanadium, andzirconium. In still another and/or alternative non-limiting composition,the content of molybdenum and rhenium in the novel metal alloy is atleast about 98 wt. % of one or more metals selected from the groupconsisting of hafnium, niobium, osmium, platinum, technetium, titanium,tungsten, vanadium, and zirconium. In yet another and/or alternativenon-limiting composition, the content of molybdenum and rhenium in thenovel metal alloy is at least about 99 wt. % of one or more metalsselected from the group consisting of hafnium, niobium, osmium,platinum, technetium, titanium, tungsten, vanadium, and zirconium. Instill yet another and/or alternative non-limiting composition, thecontent of molybdenum and rhenium in the novel metal alloy is at leastabout 99.5 wt. % of one or more metals selected from the group ofhafnium, niobium, osmium, platinum, technetium, titanium, tungsten,vanadium, and zirconium. In a further non-limiting composition, thecontent of molybdenum and rhenium in the novel metal alloy is at leastabout 99.9 wt. % of one or more metals selected from the groupconsisting of hafnium, niobium, osmium, platinum, technetium, titanium,tungsten, vanadium, and zirconium. As can be appreciated, other weightpercentages of the rhenium and molybdenum content of the novel metalalloy can be used.

In one non-limiting composition, the purity level of the novel metalalloy is such so as to produce a solid solution of the novel metalalloy. A solid solution or homogeneous solution is defined as a metalalloy that includes two or more primary metals and the combined wt. % ofthe primary metals is at least about 95 wt. %, typically at least about99 wt. %, more typically at least about 99.5 wt. %, even more typicallyat least about 99.8 wt. %, and still even more typically at least about99.9 wt. %. A primary metal is a metal component of the metal alloy thatis not a metal impurity. A solid solution of a novel metal alloy thatincludes rhenium and molybdenum as the primary metals is an alloy thatincludes at least about 95-99 wt. % rhenium and molybdenum. It isbelieved that a purity level of less than 95 wt. % molybdenum andrhenium adversely affects one or more physical properties of the metalalloy that are useful or desired in forming and/or using a medicaldevice. In one non-limiting composition, the rhenium content of thenovel metal alloy is at least about 20 wt. %. In another non-limitingcomposition, the rhenium content of the novel metal alloy is at leastabout 30 wt. %. In yet another non-limiting composition, the rheniumcontent of the novel metal alloy is at least about 40 wt. %. In anotherand/or alternative non-limiting composition, the rhenium content of thenovel metal alloy is about 45 wt. %. In still another and/or alternativenon-limiting composition, the rhenium content of the novel metal alloyis about 45-50 wt. %. In yet another and/or alternative non-limitingcomposition, the rhenium content of the novel metal alloy is about 4748wt. %. In still yet another and/or alternative non-limiting composition,the rhenium content of the novel metal alloy is about 47.6-49.5 wt. %.As can be appreciated, other weight percentages of the rhenium contentof the novel metal alloy can be used. In another and/or alternativeembodiment of the invention, the molybdenum content of the novel metalalloy in accordance with the present invention is at least about 35 wt.%. In one non-limiting composition, the molybdenum content of the novelmetal alloy is at least about 20 wt. %. In another non-limitingcomposition, the molybdenum content of the novel metal alloy is at leastabout 40 wt. %. In yet another non-limiting composition, the molybdenumcontent of the novel metal alloy is at least about 45 wt. %. In stillanother and/or alternative non-limiting composition, the molybdenumcontent of the novel metal alloy is at least about 50 wt. %. In yetanother and/or alternative non-limiting composition, the molybdenumcontent of the novel metal alloy is about 50-60 percent. In still yetanother and/or alternative non-limiting composition, the molybdenumcontent of the novel metal alloy is about 50-56 wt. %. In another and/oralternative non-limiting composition, the molybdenum content of thenovel metal alloy is about 35-90 wt. %, and the rhenium content of thenovel metal alloy is about 35-90 wt. %. In still another and/oralternative non-limiting composition, the molybdenum content of thenovel metal alloy is about 35-90 wt. %, and the rhenium content of thenovel metal alloy is about 35-90 wt. % and the combined rhenium contentand molybdenum content of the novel metal alloy is about 50-100 wt. %.As can be appreciated, other weight percentages of the molybdenumcontent of the novel metal alloy can be used.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the novel metal alloy that is used to form all or aportion of the medical device is a novel metal alloy that includes atleast about 55 wt. % molybdenum and rhenium, and at least one additionalmetal which includes hafnium, niobium, osmium, platinum, technetium,titanium, tungsten, vanadium, and/or zirconium. The addition ofcontrolled amounts of hafnium, niobium, osmium, platinum, technetium,titanium, tungsten, vanadium, and/or zirconium to the molybdenum andrhenium alloy has been found to form a metal alloy that has improvedphysical properties over a metal alloy that principally includesmolybdenum and rhenium. For instance, the addition of controlled amountsof hafnium, niobium, osmium, platinum, technetium, titanium, tungsten,vanadium, and/or zirconium to the molybdenum and rhenium alloy canresult in 1) an increase in yield strength of the alloy as compared to ametal alloy that principally includes molybdenum and rhenium, 2) anincrease in tensile elongation of the alloy as compared to a metal alloythat principally includes molybdenum and rhenium, 3) an increase inductility of the alloy as compared to a metal alloy that principallyincludes molybdenum and rhenium, 4) a reduction in grain size of thealloy as compared to a metal alloy that principally includes molybdenumand rhenium, 5) a reduction in the amount of free carbon, oxygen and/ornitrogen in the alloy as compared to a metal alloy that principallyincludes molybdenum and rhenium, and/or 6) a reduction in the tendencyof the alloy to form micro-cracks during the forming of the alloy into amedical device as compared to the forming of a medical device from ametal alloy that principally includes molybdenum and rhenium. In onenon-limiting composition, the content of molybdenum and rhenium and theat least one additional metal in the novel metal alloy is at least about90 wt. %. In another and/or alternative non-limiting composition, thecontent of molybdenum and rhenium and the at least one additional metalin the novel metal alloy is at least about 95 wt. %. In still anotherand/or alternative non-limiting composition, the content of molybdenumand rhenium and the at least one additional metal in the novel metalalloy is at least about 98 wt. %. In yet another and/or alternativenon-limiting composition, the content of molybdenum and rhenium and theat least one additional metal in the novel metal alloy is at least about99 wt. %. In still yet another and/or alternative non-limitingcomposition, the content of molybdenum and rhenium and the at least oneadditional metal in the novel metal alloy is at least about 99.5 wt. %.In a further one non-limiting composition, the content of molybdenum andrhenium and the at least one additional metal in the novel metal alloyis at least about 99.9 wt. %. As can be appreciated, other weightpercentages of the content of molybdenum and rhenium and the at leastone additional metal in the novel metal alloy can be used. The combinedcontent of hafnium, niobium, osmium, platinum, technetium, titanium,tungsten, vanadium, and/or zirconium in the novel metal alloy isgenerally less than 45 wt. %, typically less than about 25 wt. %, moretypically less than about 10 wt. %, still more typically less than about5 wt. %, yet more typically no more than about 1 wt. %, and still yetmore typically no more than about 0.5 wt. %.

In still another and/or alternative non-limiting aspect of the presentinvention, the novel metal alloy includes less than about 5 wt. % othermetals and/or impurities (e.g., 0%, 0.001%, 0.002% . . . 4.997%, 4.998%,4.999% and any value or range therebetween). A high purity level of thenovel metal alloy results in the formation of a more homogeneous alloy,which in turn results in a more uniform density throughout the novelmetal alloy, and also results in the desired yield and ultimate tensilestrength of the novel metal alloy. The density of the novel metal alloyis generally at least about 10 gm/cc, and typically at least about13-13.5 gm/cc. This substantially uniform high density of the novelmetal alloy significantly improves the radiopacity of the novel metalalloy. In one non-limiting composition, the novel metal alloy includesless than about 1 wt. % other metals and/or impurities. In anotherand/or alternative non-limiting composition, the novel metal alloyincludes less than about 0.5 wt. % other metals and/or impurities. Instill another and/or alternative non-limiting composition, the novelmetal alloy includes less than about 0.4 wt. % other metals and/orimpurities. In yet another and/or alternative non-limiting composition,the novel metal alloy includes less than about 0.2 wt. % other metalsand/or impurities. In still yet another and/or alternative non-limitingcomposition, the novel metal alloy includes less than about 0.1 wt. %other metals and/or impurities. In a further and/or alternativenon-limiting composition, the novel metal alloy includes less than about0.05 wt. % other metals and/or impurities. In still a further and/oralternative non-limiting composition, the novel metal alloy includesless than about wt. % other metals and/or impurities. In yet a furtherand/or alternative non-limiting composition, the novel metal alloyincludes less than about 0.01 wt. % other metals and/or impurities. Ascan be appreciated, other weight percentages of the amount of othermetals and/or impurities in the novel metal alloy can exist.

In yet another and/or alternative non-limiting aspect of the presentinvention, the novel alloy includes a certain amount of carbon andoxygen; however, this is not required. These two elements have beenfound to affect the forming properties and brittleness of the novelalloy. The controlled atomic ratio of carbon and oxygen of the novelalloy also can be used to minimize the tendency of the novel alloy toform micro-cracks during the forming of the novel alloy into a medicaldevice, and/or during the use and/or expansion of the medical device ina body passageway. The control of the atomic ratio of carbon to oxygenin the novel alloy allows for the redistribution of oxygen in the novelalloy so as to minimize the tendency of micro-cracking in the novelalloy during the forming of the novel alloy into a medical device,and/or during the use and/or expansion of the medical device in a bodypassageway. The atomic ratio of carbon to oxygen in the novel alloy isbelieved to be important in minimizing the tendency of micro-cracking inthe novel alloy and improving the degree of elongation of the novelalloy, both of which can affect one or more physical properties of thenovel alloy that are useful or desired in forming and/or using themedical device. The carbon to oxygen atomic ratio can be as low as about0.2:1. In one non-limiting formulation, the carbon to oxygen atomicratio in the metal alloy is generally at least about 0.3:1 (i.e., weightratio of about 0.4:1). In another non-limiting formulation, the carbonto oxygen atomic ratio in the metal alloy is generally at least about0.375:1 (i.e., weight ratio of about 0.5:1). In still anothernon-limiting formulation, the carbon to oxygen atomic ratio in the metalalloy is generally at least about 0.75:1 (i.e., weight ratio of about1:1). In yet another non-limiting formulation, the carbon to oxygenatomic ratio in the metal alloy is generally at least about 1.5:1 (i.e.,weight ratio of about 2:1). In still yet another non-limitingformulation, the carbon to oxygen atomic ratio in the metal alloy isgenerally at least about 1.88:1 (i.e., weight ratio of about 2.55:1). Instill another non-limiting formulation, the carbon to oxygen atomicratio in the metal alloy is generally at least about 2.25:1 (i.e.,weight ratio of about 3:1). In yet another non-limiting formulation, thecarbon to oxygen atomic ratio in the metal alloy is generally at leastabout 3:1 (i.e., weight ratio of about 4:1). In still yet anothernon-limiting formulation, the carbon to oxygen atomic ratio in the metalalloy is generally at least about 3.75:1 (i.e., weight ratio of about5:1). In still another non-limiting formulation, the carbon to oxygenatomic ratio in the metal alloy, is generally about 1.88-50:1 (i.e.,weight ratio of about 2.5-37.54:1). In a further non-limitingformulation, the carbon to oxygen atomic ratio in the metal alloy isgenerally about 1.88-20:1 (i.e., weight ratio of about 2.5-15:1). In afurther non-limiting formulation, the carbon to oxygen atomic ratio inthe metal alloy is generally about 1.88-13.3:1 (i.e., weight ratio ofabout 2.5-10:1). In still a further non-limiting formulation, the carbonto oxygen atomic ratio in the metal alloy is generally about 1.88-10:1(i.e., weight ratio of about 2.5-7.5:1). In yet a further non-limitingformulation, the carbon to oxygen atomic ratio in the metal alloy isgenerally about 1.88-5:1 (i.e., weight ratio of about 2.5-3.75:1). Ascan be appreciated, other atomic ratios of the carbon to oxygen in thenovel alloy can be used.

The carbon to oxygen ratio can be adjusted by intentionally addingcarbon to the novel alloy until the desired carbon to oxygen ratio isobtained. Typically, the carbon content of the novel alloy is less thanabout 0.3 wt. %. Carbon contents that are too large can adversely affectthe physical properties of the novel alloy. In one non-limitingformulation, the carbon content of the novel alloy is less than about0.1 wt. % of the novel alloy. In another non-limiting formulation, thecarbon content of the novel alloy is less than about 0.05 wt. % of thenovel alloy of the novel alloy. In still another non-limitingformulation, the carbon content of the novel alloy is less than aboutwt. % of the novel alloy. When carbon is not intentionally added to thenovel alloy of the novel alloy, the novel alloy can include up to about150 ppm carbon, typically up to about 100 ppm carbon, and more typicallyless than about 50 ppm carbon. The oxygen content of the novel alloy canvary depending on the processing parameters used to form the novel alloyof the novel alloy. Generally, the oxygen content is to be maintained atvery low levels. In one non-limiting formulation, the oxygen content isless than about 0.2 wt. % of the novel alloy. In another non-limitingformulation, the oxygen content is less than about 0.05 wt. % of thenovel alloy. In still another non-limiting formulation, the oxygencontent is less than about 0.04 wt. % of the novel alloy. In yet anothernon-limiting formulation, the oxygen content is less than about 0.03 wt.% of the novel alloy. In still yet another non-limiting formulation, thenovel alloy includes up to about 100 ppm oxygen. In a furthernon-limiting formulation, the novel alloy includes up to about 75 ppmoxygen. In still a further non-limiting formulation, the novel alloyincludes up to about 50 ppm oxygen. In yet a further non-limitingformulation, the novel alloy includes up to about 30 ppm oxygen. Instill yet a further non-limiting formulation, the novel alloy includesless than about 20 ppm oxygen. In yet a further non-limitingformulation, the novel alloy includes less than about 10 ppm oxygen. Ascan be appreciated, other amounts of carbon and/or oxygen in the novelalloy can exist. It is believed that the novel alloy will have a verylow tendency to form micro-cracks during the formation of the medicaldevice (e.g., stent, dental implant, bone implant, prosthetic implant,orthopedic device, etc.) and after the medical device has been insertedinto a patient by closely controlling the carbon to oxygen ration whenthe oxygen content exceeds a certain amount in the novel alloy. In onenon-limiting arrangement, the carbon to oxygen atomic ratio in the novelalloy is at least about 2.5:1 when the oxygen content is greater thanabout 100 ppm in the novel alloy.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the novel alloy includes a controlled amount ofnitrogen; however, this is not required. Large amounts of nitrogen inthe novel alloy can adversely affect the ductility of the novel alloy ofthe novel alloy. This can in turn adversely affect the elongationproperties of the novel alloy. A too high amount of nitrogen content inthe novel alloy can begin to cause the ductility of the novel alloy ofthe novel alloy to unacceptably decrease, thus adversely affect one ormore physical properties of the novel alloy that are useful or desiredin forming and/or using the medical device. In one non-limitingformulation, the novel alloy includes less than about 0.05 wt. %nitrogen. In another non-limiting formulation, the novel alloy includesless than about 0.0008 wt. % nitrogen. In still another non-limitingformulation, the novel alloy includes less than about 0.0004 wt. %nitrogen. In yet another non-limiting formulation, the novel alloyincludes less than about 30 ppm nitrogen. In still yet anothernon-limiting formulation, the novel alloy includes less than about 25ppm nitrogen. In still another non-limiting formulation, the novel alloyincludes less than about 10 ppm nitrogen. In yet another non-limitingformulation, the novel alloy of the novel alloy includes less than about5 ppm nitrogen. As can be appreciated, other amounts of nitrogen in thenovel alloy can exist.

The relationship of carbon, oxygen and nitrogen in the novel alloy isalso believed to be important. It is believed that the nitrogen contentshould be less than the content of carbon or oxygen in the novel alloy.In one non-limiting formulation, the atomic ratio of carbon to nitrogenis at least about 2:1 (i.e., weight ratio of about 1.71:1). In anothernon-limiting formulation, the atomic ratio of carbon to nitrogen is atleast about 3:1 (i.e., weight ratio of about 2.57:1). In still anothernon-limiting formulation, the atomic ratio of carbon to nitrogen isabout 4-100:1 (i.e., weight ratio of about 3.43-85.7:1). In yet anothernon-limiting formulation, the atomic ratio of carbon to nitrogen isabout 4-75:1 (i.e., weight ratio of about 3.43-64.3:1). In still anothernon-limiting formulation, the atomic ratio of carbon to nitrogen isabout 4-50:1 (i.e., weight ratio of about 3.43-42.85:1). In yet anothernon-limiting formulation, the atomic ratio of carbon to nitrogen isabout 4-35:1 (i.e., weight ratio of about 3.43-30:1). In still yetanother non-limiting formulation, the atomic ratio of carbon to nitrogenis about 4-25:1 (i.e., weight ratio of about 3.43-21.43:1). In a furthernon-limiting formulation, the atomic ratio of oxygen to nitrogen is atleast about 1.2:1 (i.e., weight ratio of about 1.37:1). In anothernon-limiting formulation, the atomic ratio of oxygen to nitrogen is atleast about 2:1 (i.e., weight ratio of about 2.28:1). In still anothernon-limiting formulation, the atomic ratio of oxygen to nitrogen isabout 3-100:1 (i.e., weight ratio of about 3.42-114.2:1). In yet anothernon-limiting formulation, the atomic ratio of oxygen to nitrogen is atleast about 3-75:1 (i.e., weight ratio of about 3.4285.65:1). In stillyet another non-limiting formulation, the atomic ratio of oxygen tonitrogen is at least about 3-55:1 (i.e., weight ratio of about3.42-62.81:1). In yet another non-limiting formulation, the atomic ratioof oxygen to nitrogen is at least about 3-50:1 (i.e., weight ratio ofabout 3.42-57.1:1).

In a further and/or alternative non-limiting aspect of the presentinvention, the metal alloy has several physical properties thatpositively affect the medical device when at least partially formed ofthe metal alloy. In one non-limiting embodiment of the invention, theaverage Vickers hardness of the metal alloy tube used to form themedical device is generally at least about 234 DHP (i.e., Rockwell Ahardness of at least about 60 at 77° F., Rockwell C hardness of at leastabout 19 at 77° F.). In one non-limiting aspect of this embodiment, theaverage hardness of the metal alloy used to form the medical device isgenerally at least about 248 DHP (i.e., Rockwell A hardness of at leastabout 62 at 77° F., Rockwell C hardness of at least about 22 at 77° F.).In another and/or additional non-limiting aspect of this embodiment, theaverage hardness of the metal alloy used to form the medical device isgenerally about 248-513 DHP (i.e., Rockwell A hardness of about 62-76 at77° F., Rockwell C hardness of about 22-50 at 77° F.). In still anotherand/or additional non-limiting aspect of this embodiment, the averagehardness of the metal alloy used to form the medical device is generallyabout 272-458 DHP (i.e., Rockwell A hardness of about 64-74 at 77° F.,Rockwell C hardness of about 26-46 at 77° F.). When hafnium, niobium,osmium, platinum, technetium, titanium, tungsten, vanadium, yttriumand/or zirconium are included in an alloy of molybdenum and rhenium, theaverage hardness of the metal alloy is generally increased. In anotherand/or alternative non-limiting embodiment of the invention, the averageultimate tensile strength of the metal alloy used to form the medicaldevice is generally at least about 60 UTS (ksi). In non-limiting aspectof this embodiment, the average ultimate tensile strength of the metalalloy used to form the medical device is generally at least about 70 UTS(ksi), typically about 80-320 UTS (ksi), and more typically about100-310 UTS (ksi). The average ultimate tensile strength of the metalalloy can vary somewhat when the metal alloy is in the form of a tube ora solid wire. When the metal alloy is in the form of a tube, the averageultimate tensile strength of the metal alloy tube is generally about80-150 UTS (ksi), typically at least about 110 UTS (ksi), and moretypically 110-140 UTS (ksi). When the metal alloy is in the form of asolid wire, the average ultimate tensile strength of the metal alloywire is generally about 120-310 UTS (ksi). In still another and/oralternative non-limiting embodiment of the invention, the average yieldstrength of the metal alloy used to form the medical device is at leastabout 70 ksi. In one non-limiting aspect of this embodiment, the averageyield strength of the metal alloy used to form the medical device is atleast about 80 ksi, and typically about 100-140 (ksi). In yet anotherand/or alternative non-limiting embodiment of the invention, the averagegrain size of the metal alloy used to form the medical device is nogreater than about 4 ASTM (e.g., ASTM 112-96). A grain size as small asabout 14-15 ASTM can be achieved; however, the grain size is typicallylarger than 15 ASTM. The small grain size of the metal alloy enables themedical device to have the desired elongation and ductility propertiesthat are useful in enabling the medical device to be formed, crimpedand/or expanded. In one non-limiting aspect of this embodiment, theaverage grain size of the metal alloy used to form the medical device isabout 5.2-10 ASTM, typically about 5.5-9 ASTM, more typically about 6-9ASTM, still more typically about 6-9 ASTM, even more typically about6.6-9 ASTM, and still even more typically about 7-8.5 ASTM.

In still yet another and/or alternative non-limiting embodiment of theinvention, the average tensile elongation of the metal alloy used toform the medical device is at least about 25%. An average tensileelongation of at least 25% for the metal alloy is important to enablethe medical device to be properly expanded when positioned in thetreatment area of a body passageway. A medical device that does not havean average tensile elongation of at least about 25% can formmicro-cracks and/or break during the forming, crimping and/or expansionof the medical device. In one non-limiting aspect of this embodiment,the average tensile elongation of the metal alloy used to form themedical device is about 25-35%. The unique combination of the rheniumand molybdenum in the metal alloy, in combination with achieving thedesired purity and composition of the alloy and the desired grain sizeof the metal alloy, results in 1) a medical device having the desiredhigh ductility at about room temperature, 2) a medical device having thedesired amount of tensile elongation, 3) a homogeneous or solid solutionof a metal alloy having high radiopacity, 4) a reduction or preventionof micro-crack formation and/or breaking of the metal alloy tube whenthe metal alloy tube is sized and/or cut to form the medical device, 5)a reduction or prevention of micro-crack formation and/or breaking ofthe medical device when the medical device is crimped onto a balloonand/or other type of medical device for insertion into a bodypassageway, 6) a reduction or prevention of micro-crack formation and/orbreaking of the medical device when the medical device is bent and/orexpanded in a body passageway, 7) a medical device having the desiredultimate tensile strength and yield strength, 8) a medical device thatcan have very thin wall thicknesses and still have the desired radialforces needed to retain the body passageway on an open state when themedical device has been expanded, and/or 9) a medical device thatexhibits less recoil when the medical device is crimped onto a deliverysystem and/or expanded in a body passageway.

In still a further and/or alternative non-limiting aspect of the presentinvention, the metal alloy is at least partially formed by a swagingprocess. In one non-limiting embodiment, the medical device includes oneor more rods or tubes upon which swaging is performed to at leastpartially or fully achieve final dimensions of one or more portions ofthe medical device. The swaging dies can be shaped to fit the finaldimension of the medical device; however, this is not required. Wherethere are undercuts of hollow structures in the medical device (which isnot required), a separate piece of metal can be in placed in theundercut to at least partially fill the gap. The separate piece of metal(when used) can be designed to be later removed from the undercut;however, this is not required. The swaging operation can be performed onthe medical device in the areas to be hardened. For a round or curvedportion of a medical device, the swaging can be rotary. For a non-roundportion of the medical device, the swaging of the non-round portion ofthe medical device can be performed by non-rotating swaging dies. Thedies can optionally be made to oscillate in radial and/or longitudinaldirections instead of or in addition to rotating. The medical device canoptionally be swaged in multiple directions in a single operation or inmultiple operations to achieve a hardness in desired location and/ordirection of the medical device. The swaging temperature for aparticular metal alloy (e.g., MoRe alloy, etc.) can vary. For a MoRealloy, the swaging temperature can be from room temperature (e.g.,65-75° F.) to about 400° C. if the swaging is conducted in air or anoxidizing environment. The swaging temperature can be increased to up toabout 1500° C. if the swaging process is performed in a controlledneutral or non-reducing environment (e.g., inert environment). Theswaging process can be conducted by repeatedly hammering the medicaldevice at the location to be hardened at the desired swagingtemperature. In one non-limiting embodiment, during the swaging processions of boron and/or nitrogen are allowed to impinge upon rhenium atomsin the MoRe alloy so as to form ReB2, ReN2 and/or ReN3; however, this isnot required. If has been found that ReB2, ReN2 and/or ReN3 areultra-hard compounds. In another and/or alternative non-limitingembodiment, all or a portion of the metal alloy coating (e.g., MoRealloy coating) can be coated with another metal alloy (e.g., titaniumalloy, etc.); however, this is not required. The coated metal alloy canhave a hardness at room temperature that is greater than the hardness ofthe metal alloy in the core; however, this is not required. Generally,the coated alloy has a melting point that is less than the melting pointof the material that forms the core; however, this is not required. Forexample, if the medical device is formed of MoRe, one or more portionsof the MoRe implant can be coated by dipping in a molten material suchas titanium-5 alloy. The melting temperature of titanium-5 alloy isabout 1660° C. and MoRe has a melting temperature of about 2450° C. Dueto the higher melting temperature of MoRe, the coating of titanium-5alloy on the MoRe results in the MoRe maintaining its shape after thecoating process. In one non-limiting process, the metal for the medicaldevice can be machined and shaped into the medical device when the metalis in a less hardened state. As such, the raw starting material can befirst annealed to soften and then machined into the metal into a desiredshape. After the metal alloy is shaped, the metal alloy can bere-hardened. The hardening of the metal material of the medical devicecan improve the wear resistance and/or shape retention of the medicaldevice. The metal material of the medical generally cannot bere-hardened by annealing, thus a special rehardening processes isrequired. Such rehardening can be achieved by the swaging process of thepresent invention.

In another and/or alternative non-limiting embodiment, all or a portionof the metal alloy can be coated with another metal alloy (e.g.,titanium alloy, etc.); however, this is not required. The coated metalalloy can have a hardness at RT that is greater than the hardness of themetal alloy in the core; however, this is not required. Generally, thecoated alloy has a melting point that is less than the melting point ofthe material that forms the core; however, this is not required. Forexample, if the medical device is formed of the novel MoRe of thepresent invention, one or more portions of the MoRe implant can becoated by dipping in a molten material such as titanium-5 alloy. Themelting temperature of titanium-5 alloy is about 1660° C. and MoRe has amelting temperature of about 2450° C. Due to the higher meltingtemperature of MoRe, the coating of titanium-5 alloy on the MoRe resultsin the MoRe maintaining its shape after the coating process. In onenon-limiting process, the metal for the medical device can be machinedand shaped into the medical device when the metal is in a less hardenedstate. As such, the raw starting material can be first annealed tosoften and then machined into the metal into a desired shape. After themetal alloy is shaped, the metal alloy can be re-hardened. The hardeningof the metal material of the medical device can improve the wearresistance and/or shape retention of the medical device. The metalmaterial of the medical generally cannot be re-hardened by annealing,thus a special rehardening processes is required. Such rehardening canbe achieved by the swaging process of the present invention.

Several non-limiting examples of the metal alloy that can be made inaccordance with the present invention are set forth below:

Metal/Wt. % Ex. 1 Ex. 2 Ex. 3 C <150 ppm 51-54% <50 ppm 52.5-<50 ppm Mo<50 ppm <20 ppm 5.5% <10 50.5-52.4% O 46-49% ppm <10 ppm <10 ppm

Metal/Wt. % Ex. 4 Ex. 5 Ex. 6 Ex. 7 C ≤50 ppm ≤50 ppm ≤50 ppm ≤50 ppm Mo51-54% 52.5-55.5% 52-56% 52.5-55% O ≤20 ppm ≤20 ppm ≤10 ppm <10 ppm N≤20 ppm ≤20 ppm ≤10 ppm ≤10 ppm Re 46-49% 44.5-47.5% 44-48% 45-47.5%Metal/Wt. % Ex. 8 Ex. 9 Ex. 10 Ex. 11 C ≤40 ppm ≤40 ppm ≤40 ppm ≤40 ppmMo 50.5-53% 51.5-54% 52-55% 52.5-55% O ≤15 ppm ≤15 ppm ≤15 ppm ≤10 ppm N≤10 ppm ≤10 ppm ≤10 ppm ≤10 ppm Re 47-49.5% 46-48.5% 45-48% 45-47.5%Metal/Wt. % Ex. 12 Ex. 13 Ex. 14 Ex. 15 C ≤40 ppm ≤40 ppm <150 ppm <150ppm Mo 52-55% 52.5-55.5% 50-60% 50-60% O ≤10 ppm ≤10 ppm ≤100 ppm ≤100ppm N ≤10 ppm ≤10 ppm ≤40 ppm ≤40 ppm Re 45-49% 44.5-47.5% 40-50% 40-50%Metal/Wt. % Ex. 16. Ex. 17 Ex. 18 Ex. 19 C ≤150 ppm ≤150 ppm ≤150 ppm≤150 ppm Mo 50-55% 52-55.5% 51-58% 50-56% O ≤100 ppm ≤100 ppm ≤100 ppm≤100 ppm N ≤40 ppm ≤20 ppm ≤20 ppm ≤20 ppm Re 45-50% 44.5-48% 42-49%44-50% Metal/Wt. % Ex. 20 Ex. 21 Ex. 22 C <150 ppm <50 ppm <50 ppm Mo51-54% 52.5-55.5% 50.5-52.4% O <50 ppm <10 ppm <10 ppm N <20 ppm <10 ppm<10 ppm Re 46-49% 44.5-47.5% 47.6-49.5% Metal/Wt. % Ex. 23 Ex. 24 Ex. 25C ≤150 ppm ≤150 ppm ≤150 ppm Mo 50-60% 50-60% 50-55% O ≤100 ppm ≤100 ppm≤100 ppm N ≤40 ppm ≤40 ppm ≤40 ppm Re 40-50% 40-50% 45-50% Metal/Wt. %Ex. 26 Ex. 27 Ex. 28 C ≤150 ppm ≤150 ppm ≤150 ppm Mo 52-55.5% 51-58%50-56% O ≤100 ppm ≤100 ppm ≤100 ppm N 20 ppm <20 ppm 520 ppm Re 44.5-48%42-49% 44-50% Metal/Wt. % Ex. 29 Ex. 30 Ex. 31 Ex. 32 C ≤50 ppm ≤50 ppm≤50 ppm ≤50 ppm Mo 51-54% 52.5-55.5% 52-56% 52.5-55% O ≤20 ppm ≤20 ppm≤10 ppm ≤10 ppm N ≤20 ppm ≤20 ppm ≤10 ppm ≤10 ppm Re 46-49% 44.5-47.5%44-48% 45-47.5% Metal/Wt. % Ex. 33 Ex. 34 Ex. 35 Ex. 36 C ≤40 ppm ≤40ppm ≤40 ppm ≤40 ppm Mo 50.5-53% 51.5-54% 52-55% 52.5-55% O ≤15 ppm ≤15ppm ≤15 ppm ≤10 ppm N ≤10 ppm ≤10 ppm ≤10 ppm ≤10 ppm Re 47-49.5%46-48.5% 45-48% 45-47.5% Metal/Wt. % Ex. 37 Ex. 38 C ≤40 ppm ≤40 ppm Mo52-55% 52.5-55.5% O ≤10 ppm ≤10 ppm N ≤10 ppm ≤10 ppm Re 45-49%44.5-47.5% Metal/Wt. % Ex. 39 C ≤150 ppm CNT ≤10% Co ≤0.1% Fe ≤0.1% H≤0.002% Hf ≤5% Mo 20-80% O ≤100 ppm Os ≤5% N ≤40 ppm Nb ≤5% Ni ≤0.1% Pt≤5% Rare Earth ≤1% Metal Re 20-80% Ta ≤3% Tc ≤5% Ti ≤1% V ≤5% W ≤3% Y≤0.1% Zn ≤0.1% Zr ≤5% Metal/Wt. % Ex. 40 C ≤0.01% CNT ≤1% Co ≤0.002% Fe≤0.02% H ≤0.002% Hf ≤1% Mo 40-60% N ≤40 ppm Nb ≤1% Ni ≤0.05% O ≤100 ppmOs ≤1% Pt ≤1% Rare Earth ≤0.1% Metal Re 40-60% S ≤0.008% Sn ≤0.002% Ta≤0.1% Tc ≤1% Ti ≤1% V ≤1% W ≤1% Y ≤0.1% Zn ≤0.1% Zr ≤1% Metal/Wt. % Ex.41 C ≤0.01% CNT ≤0.1% Co ≤0.002% Fe ≤0.02% H ≤0.002% Hf ≤0.5% Mo 40-60%N ≤40 ppm Nb ≤0.5% Ni ≤0.01% O ≤100 ppm Os ≤0.5% Pt ≤0.5% Rare Earth≤0.05% Metal Re 40-60% S ≤0.008% Sn ≤0.002% Ta ≤0.05% Tc ≤0.5% Ti ≤0.5%V ≤0.5% W ≤0.5% Y ≤0.05% Zr ≤0.5% Metal/Wt. % Ex. 42 C ≤150 ppm Hf ≤5%Mo 20-90% O ≤100 ppm Os ≤5% N ≤40 ppm Nb ≤5% Pt ≤5% Rare Earth ≤4% MetalRe 10-80% Ta ≤3% Tc ≤5% Ti ≤1% V ≤5% W ≤3% Y ≤0.1% Zn ≤0.1% Zr ≤5% CNT0.05-10% Metal/Wt. % Ex. 43 C ≤0.01% Co ≤0.002% Fe ≤0.02% H ≤0.002% Hf≤1% Mo 40-90% N ≤0.0008% Nb ≤1% Ni ≤0.01% O ≤0.06% Os ≤1% Pt ≤1% Re10-60% S ≤0.008% Sn ≤0.002% Tc ≤1% Ti ≤1% V ≤1% W ≤1% Zr ≤1% CNT 0.5-5%Metal/Wt. % Ex. 44 C ≤150 ppm Hf ≤5% Mo 20-80% O ≤100 ppm Os ≤5% N ≤40ppm Nb ≤5% Pt ≤5% Rare Earth ≤4% Metal Re 20-80% Ta ≤3% Tc ≤5% Ti ≤1% V≤5% W ≤3% Y ≤0.1% Zn ≤0.1% Zr ≤5% Metal/Wt. % Ex. 45 C ≤0.01% Co ≤0.002%Fe ≤0.02% H ≤0.002% Hf ≤1% Mo 40-60% N ≤0.0008% Nb ≤1% Ni ≤0.01% O≤0.06% Os ≤1% Pt ≤1% Re 40-60% S ≤0.008% Sn ≤0.002% Tc ≤1% Ti ≤1% V ≤1%W ≤1% Zr ≤1% Metal/Wt. % Ex. 46 Ex. 47 Ex. 48 Ex. 49 Mo 40-99.89%40-99.9% 40-99.89% 40-99.5% C 0.01-0.3% 0-0.3% 0-0.3% 0-0.3% Co ≤0.002%≤0.002% ≤0.002% ≤0.002% Cs2O 0-0.2% 0-0.2% 0.01-0.2% 0-0.2% Fe ≤0.02%≤0.02% ≤0.02% ≤0.02% H ≤0.002% ≤0.002% ≤0.002% ≤0.002% Hf 0.1-2.5%0-2.5% 0-2.5% 0-2.5% O ≤0.06% ≤0.06% ≤0.06% ≤0.06% Os ≤1% ≤1% ≤1% ≤1%La2O3 0-2% 0.1-2% 0-2% 0-2% N ≤20 ppm ≤20 ppm ≤20 ppm ≤20 ppm Nb ≤0.01%≤0.01% ≤0.01% ≤0.01% Pt ≤1% ≤1% ≤1% ≤1% Re 0-40% 0-40% 0-40% 0-40% S≤0.008% ≤0.008% ≤0.008% ≤0.008% Sn ≤0.002% ≤0.002% ≤0.002% ≤0.002% Ta0-50% 0-50% 0-50% 0-50% Tc ≤1% ≤1% ≤1% ≤1% Ti ≤1% ≤1% ≤1% ≤1% V ≤1% ≤1%≤1% ≤1% W 0-50% 0-50% 0-50% 0.5-50% Y2O3 0-1% 0-1% 0.1-1% 0-1% Zr ≤1%≤1% ≤1% ≤1% ZrO2 0-3% 0-3% 0-3% 0-3% CNT 0-10% 0-10% 0-10% 0-10%Metal/Wt. % Ex. 50 Ex. 51 Ex. 52 Mo 40-99.9% 40-99.5% 40-99.5% C 0-0.3%0-0.3% 0-0.3% Co ≤0.002% ≤0.002% ≤0.002% Cs2O 0-0.2% 0-0.2% 0-0.2% H≤0.002% ≤0.002% ≤0.002% Hf 0-2.5% 0-2.5% 0-2.5% O ≤0.06% ≤0.06% ≤0.06%Os ≤1% ≤1% ≤1% La2O3 0-2% 0-2% 0-2% N ≤20 ppm ≤20 ppm ≤20 ppm Nb ≤0.01%≤0.01% ≤0.01% Pt ≤1% ≤1% ≤1% Re 0-40% 0-40% 0.5-40% S ≤0.008% ≤0.008%≤0.008% Sn ≤0.002% ≤0.002% ≤0.002% Ta 0-50% 0.5-50% 0-50% Tc ≤1% ≤1% ≤1%Ti ≤1% ≤1% ≤1% V ≤1% ≤1% ≤1% W 0-50% 0-50% 0-50% Y2O3 0-1% 0-1% 0-1%ZrO2 0.1-3% 0-3% 0-3% CNT 0-10% 0-10% 0-10% Metal/Wt. % Ex. 53 Ex. 54Ex. 55 Ex. 56 Mo 98-99.15% 98-99.7% 50-99.66% 40-80% C 0.05-0.15%0-0.15% 0-0.15% 0-0.15% Cs2O 0-0.2% 0-0.2% 0.04-0.1% 0-0.2% Hf 0.8-1.4%0-2.5% 0-2.5% 0-2.5% La2O3 0-2% 0.3-0.7% 0-2% 0-2% Re 0-40% 0-40% 0-40%0-40% Ta 0-50% 0-50% 0-50% 0-50% W 0-50% 0-50% 0-50% 20-50% Y2O3 0-1%0-1% 0.3-0.5% 0-1% ZrO2 0-3% 0-3% 0-3% 0-3% Metal/Wt. % Ex. 57 Ex. 58Ex. 59 Mo 97-98.8% 50-90% 60-99.5% C 0-0.15% 0-0.15% 0-0.15% Cs2O 0-0.2%0-0.2% 0-0.2% Hf 0-2.5% 0-2.5% 0-2.5% La2O3 0-2% 0-2% 0-2% Re 0-40%0-40% 5-40% Ta 0-50% 10-50% 0-50%- W 0-50% 0-50% 0-50% Y2O3 0-1% 0-1%0-1% ZrO2 1.2-1.8% 0-3% 0-3% Metal/Wt. % Ex. 60 Ex. 61 Ex. 62 Ex. 63 Fe65-80% 65-85% 65-85% 0-2% Al 0-7% 0-7% 0-7% 2-9% C 0.05-0.5% 0-0.05%0-0.15% 0-0.15% Co 5-20% 0-5% 0-5% 0-5% Cr 1-5% 4-15% 7-22% 0-4% Cu 0-8%0-2% 1-5% 0-2% Mo 0.5-4% 0.3-4% 0-2% 0-2% Nb 0-2% 0-2% 0.05-1% 0-2% Ni4-20% 4-20% 2-8% 0-2% Ti 0-3% 0.5-4% 0-3% 80-91% V 0-7% 0-3% 0-3% 2-6%

indicates data missing or illegible when filed

In the above examples, the metal alloy is principally formed of rheniumand molybdenum and the content of other metals and/or impurities is lessthan about 0.1 wt. % of the metal alloy, the atomic ratio of carbon tooxygen is about 2.5-10:1 (i.e., weight ratio of about 1.88-7.5:1), theaverage grain size of the metal alloy is about 6-10 ASTM, the tensileelongation of the metal alloy is about 25-35%, the average density ofthe metal alloy is at least about 13.4 gm/cc, the average yield strengthof the metal alloy is about 98-122 (ksi), the average ultimate tensilestrength of the metal alloy is about 150-310 UTS (ksi), and an averageVickers hardness of 372-653 (i.e., Rockwell A Hardness of about 70-80 at77° F., an average Rockwell C Hardness of about 39-58 at 77° F.). InExamples 1-38, the metal alloy is principally formed of rhenium andmolybdenum and includes one or more metals from the group consisting ofhafnium, niobium, osmium, platinum, technetium, titanium, tungsten,vanadium, and/or zirconium, and the content of other metals and/orimpurities is less than about 5 wt. % of the metal alloy. In Examples3941, the metal alloy is also principally formed of rhenium andmolybdenum and includes one or more metals from the group consisting ofhafnium, niobium, osmium, platinum, technetium, titanium, tungsten,vanadium, and/or zirconium, and the content of other metals and/orimpurities is no more than about 3 wt. % of the metal alloy. The upperlimits of hafnium, niobium, osmium, platinum, technetium, titanium,tungsten, vanadium, and/or zirconium, when included in the metal alloy,are illustrated in Examples 39-63. When the metal alloy includes one ormore of hafnium, niobium, osmium, platinum, technetium, titanium,tungsten, vanadium, and/or zirconium, the lower amount of these one ormore metals in the metal alloy is 0.01 wt. %. When one or more othermetals are included in the novel metal alloy, the lower amount of theseother metals is 0.001 wt. %. In examples 1-63, the ratio of carbon tooxygen can optionally be about 2.5-10:1, the average grain size of themetal alloy can optionally be about 6-10 ASTM, the tensile elongation ofthe metal alloy can optionally be about 25-35%, the average density ofthe metal alloy can optionally be at least about 13.6 gm/cc, the averageyield strength of the metal alloy can optionally be at least about 110(ksi), the average ultimate tensile strength of the metal alloy canoptionally be about 150-310 UTS (ksi), and an average Vickers hardnesscan optionally be about 372-653 (i.e., an average Rockwell A Hardness ofabout 70-80 at 77° F., an average Rockwell C Hardness of about 39-58 at77° F.). In another non-limiting embodiment, in Examples 1-41, the ratioof carbon to oxygen can be at least about 0.3:1 (i.e., weight ratio ofcarbon to oxygen of at least about 0.3:1), the nitrogen content can beless than the carbon content and the oxygen content, the atomic ratio ofcarbon to nitrogen can be at least about 3:1 (i.e., weight ratio ofabout 3.43:1), the atomic ratio of oxygen to nitrogen can be at leastabout 3:1 (i.e., weight ratio of about 3.42:1), the average grain sizeof metal alloy can be about 6-10 ASTM, the tensile elongation of themetal alloy can be about 25-35%, the average density of the metal alloycan be at least about 13.4 gm/cc, the average yield strength of themetal alloy can be about 98-122 (ksi), the average ultimate tensilestrength of the metal alloy can be about 100-150 UTS (ksi), and/or theaverage hardness of the metal alloy can be about 80-100 (HRC) at 77° F.

In another and/or alternative non-limiting aspect of the presentinvention, the use of the metal alloy in the medical device can increasethe strength of the medical device as compared with stainless steel orchromium-cobalt alloys, thus less quantity of metal alloy can be used inthe medical device to achieve similar strengths as compared to medicaldevices formed of different metals. As such, the resulting medicaldevice can be made smaller and less bulky by use of the metal alloywithout sacrificing the strength and durability of the medical device.Such a medical device can have a smaller profile, thus can be insertedin smaller areas, openings and/or passageways. The metal alloy can alsoincrease the radial strength of the medical device. For example, thethickness of the walls of the medical device and/or the wires used toform the medical device can be made thinner and achieve a similar orimproved radial strength as compared with thicker walled medical devicesformed of stainless steel or cobalt and chromium alloy. The metal alloyalso can improve stress-strain properties, bendability and flexibilityof the medical device and thus increase the life of the medical device.For example, the medical device can be used in regions that subject themedical device to bending. Due to the improved physical properties ofthe medical device from the metal alloy, the medical device has improvedresistance to fracturing in such frequent bending environments. Inaddition or alternatively, the improved bendability and flexibility ofthe medical device due to the use of the metal alloy can enable themedical device to be more easily inserted into a body passageway. Themetal alloy can also reduce the degree of recoil during the crimpingand/or expansion of the medical device. For example, the medical devicebetter maintains its crimped form and/or better maintains its expandedform after expansion due to the use of the metal alloy. As such, whenthe medical device is to be mounted onto a delivery device when themedical device is crimped, the medical device better maintains itssmaller profile during the insertion of the medical device in a bodypassageway. Also, the medical device better maintains its expandedprofile after expansion so as to facilitate in the success of themedical device in the treatment area. In addition to the improvedphysical properties of the medical device by use of the metal alloy, themetal alloy has improved radiopaque properties as compared to standardmaterials such as stainless steel or cobalt-chromium alloy, thusreducing or eliminating the need for using marker materials on themedical device. For instance, the metal alloy is believed to at leastabout 10-20% more radiopaque than stainless steel or cobalt-chromiumalloy. Specifically, the metal alloy is believed to be at least about33% more radiopaque than cobalt-chromium alloy and is believed to be atleast about 41.5% more radiopaque than stainless steel.

In yet another and/or alternative non-limiting aspect of the presentinvention, the medical device can include, contain and/or be coated withone or more agents that facilitate in the success of the medical deviceand/or treated area. The term “agent” includes, but is not limited to, asubstance, pharmaceutical, biologic, veterinary product, drug, andanalogs or derivatives otherwise formulated and/or designed to prevent,inhibit and/or treat one or more clinical and/or biological events,and/or to promote healing. Non-limiting examples of clinical events thatcan be addressed by one or more agents include, but are not limited to,viral, fungus and/or bacterial infection; vascular diseases and/ordisorders; digestive diseases and/or disorders; reproductive diseasesand/or disorders; lymphatic diseases and/or disorders; cancer; implantrejection; pain; nausea; swelling; arthritis; bone diseases and/ordisorders; organ failure; immunity diseases and/or disorders;cholesterol problems; blood diseases and/or disorders; lung diseasesand/or disorders; heart diseases and/or disorders; brain diseases and/ordisorders; neuralgia diseases and/or disorders; kidney diseases and/ordisorders; ulcers; liver diseases and/or disorders; intestinal diseasesand/or disorders; gallbladder diseases and/or disorders; pancreaticdiseases and/or disorders; psychological disorders; respiratory diseasesand/or disorders; gland diseases and/or disorders; skin diseases and/ordisorders; hearing diseases and/or disorders; oral diseases and/ordisorders; nasal diseases and/or disorders; eye diseases and/ordisorders; fatigue; genetic diseases and/or disorders; burns; scarringand/or scars; trauma; weight diseases and/or disorders; addictiondiseases and/or disorders; hair loss; cramps; muscle spasms; tissuerepair; nerve repair; neural regeneration and/or the like. Non-limitingexamples of agents that can be used include, but are not limited to,5-fluorouracil and/or derivatives thereof; 5-phenylmethimazole and/orderivatives thereof; ACE inhibitors and/or derivatives thereof;acenocoumarol and/or derivatives thereof; acyclovir and/or derivativesthereof; actilyse and/or derivatives thereof; adrenocorticotropichormone and/or derivatives thereof; adriamycin and/or derivativesthereof; agents that modulate intracellular Ca2+ transport such asL-type (e.g., diltiazem, nifedipine, verapamil, etc.) or T-type Ca2+channel blockers (e.g., amiloride, etc.); alpha-adrenergic blockingagents and/or derivatives thereof; alteplase and/or derivatives thereof;amino glycosides and/or derivatives thereof (e.g., gentamycin,tobramycin, etc.); angiopeptin and/or derivatives thereof; angiostaticsteroid and/or derivatives thereof; angiotensin II receptor antagonistsand/or derivatives thereof; anistreplase and/or derivatives thereof;antagonists of vascular epithelial growth factor and/or derivativesthereof; antibiotics; anti-coagulant compounds and/or derivativesthereof; anti-fibrosis compounds and/or derivatives thereof; anti-fungalcompounds and/or derivatives thereof; anti-inflammatory compounds and/orderivatives thereof; anti-invasive factor and/or derivatives thereof;anti-metabolite compounds and/or derivatives thereof (e.g.,staurosporin, trichothecenes, and modified diphtheria and ricin toxins,pseudomonas exotoxin, etc.); anti-matrix compounds and/or derivativesthereof (e.g., colchicine, tamoxifen, etc.); anti-microbial agentsand/or derivatives thereof; anti-migratory agents and/or derivativesthereof (e.g., caffeic acid derivatives, nilvadipine, etc.);anti-mitotic compounds and/or derivatives thereof; anti-neoplasticcompounds and/or derivatives thereof; anti-oxidants and/or derivativesthereof, anti-platelet compounds and/or derivatives thereof;anti-proliferative and/or derivatives thereof; anti-thrombogenic agentsand/or derivatives thereof; argatroban and/or derivatives thereof; AP-1inhibitors and/or derivatives thereof (e.g., for tyrosine kinase,protein kinase C, myosin light chain kinase, Ca2±/calmodulin kinase II,casein kinase II, etc.); aspirin and/or derivatives thereof;azathioprine and/or derivatives thereof; fl-estradiol and/or derivativesthereof; fl-1-anticollagenase and/or derivatives thereof; calciumchannel blockers and/or derivatives thereof; calmodulin antagonistsand/or derivatives thereof (e.g., H7, etc.); Capotril and/or derivativesthereof; cartilage-derived inhibitor and/or derivatives thereof; ChIMP-3and/or derivatives thereof; cephalosporin and/or derivatives thereof(e.g., cefadroxil, cefazolin, cefaclor, etc.); chloroquine and/orderivatives thereof; chemotherapeutic compounds and/or derivativesthereof (e.g., 5-fluorouracil, vincristine, vinblastine, cisplatin,doxyrubicin, adriamycin, tamocifen, etc.); chymostatin and/orderivatives thereof; Cilazapril and/or derivatives thereof; clopidigreland/or derivatives thereof; clotrimazole and/or derivatives thereof;colchicine and/or derivatives thereof; cortisone and/or derivativesthereof; coumadin and/or derivatives thereof; curacin-A and/orderivatives thereof; cyclosporine and/or derivatives thereof;cytochalasin and/or derivatives thereof (e.g., cytochalasin A,cytochalasin B, cytochalasin C, cytochalasin D, cytochalasin E,cytochalasin F, cytochalasin G, cytochalasin H, cytochalasin J,cytochalasin K, cytochalasin L, cytochalasin M, cytochalasin N,cytochalasin 0, cytochalasin P, cytochalasin Q, cytochalasin R,cytochalasin S, chaetoglobosin A, chaetoglobosin B, chaetoglobosin C,chaetoglobosin D, chaetoglobosin E, chaetoglobosin F, chaetoglobosin G,chaetoglobosin J, chaetoglobosin K, deoxaphomin, proxiphomin,protophomin, zygosporin D, zygosporin E, zygosporin F, zygosporin G,aspochalasin B, aspochalasin C, aspochalasin D, etc.); cytokines and/orderivatives thereof; desirudin and/or derivatives thereof; dexamethazoneand/or derivatives thereof; dipyridamole and/or derivatives thereof;eminase and/or derivatives thereof; endothelin and/or derivativesthereof endothelial growth factor and/or derivatives thereof; epidermalgrowth factor and/or derivatives thereof; epothilone and/or derivativesthereof; estramustine and/or derivatives thereof; estrogen and/orderivatives thereof; fenoprofen and/or derivatives thereof; fluorouraciland/or derivatives thereof; flucytosine and/or derivatives thereof;forskolin and/or derivatives thereof; ganciclovir and/or derivativesthereof; glucocorticoids and/or derivatives thereof (e.g.,dexamethazone, betamethasone, etc.); glycoprotein IIb/IIIa plateletmembrane receptor antibody and/or derivatives thereof; GM-CSF and/orderivatives thereof; griseofulvin and/or derivatives thereof; growthfactors and/or derivatives thereof (e.g., VEGF; TGF; IGF; PDGF; FGF,etc.); growth hormone and/or derivatives thereof; heparin and/orderivatives thereof; hirudin and/or derivatives thereof; hyaluronateand/or derivatives thereof; hydrocortisone and/or derivatives thereof;ibuprofen and/or derivatives thereof; immunosuppressive agents and/orderivatives thereof (e.g., adrenocorticosteroids, cyclosporine, etc.);indomethacin and/or derivatives thereof; inhibitors of thesodium/calcium antiporter and/or derivatives thereof (e.g., amiloride,etc.); inhibitors of the IP3 receptor and/or derivatives thereof;inhibitors of the sodium/hydrogen antiporter and/or derivatives thereof(e.g., amiloride and derivatives thereof, etc.); insulin and/orderivatives thereof; interferon a-2-macroglobulin and/or derivativesthereof; ketoconazole and/or derivatives thereof; lepirudin and/orderivatives thereof; Lisinopril and/or derivatives thereof; Lovastatinand/or derivatives thereof; marevan and/or derivatives thereof;mefloquine and/or derivatives thereof; metalloproteinase inhibitorsand/or derivatives thereof; methotrexate and/or derivatives thereof;metronidazole and/or derivatives thereof; miconazole and/or derivativesthereof; monoclonal antibodies and/or derivatives thereof; mutamycinand/or derivatives thereof; naproxen and/or derivatives thereof; nitricoxide and/or derivatives thereof; nitroprusside and/or derivativesthereof; nucleic acid analogues and/or derivatives thereof (e.g.,peptide nucleic acids, etc.); nystatin and/or derivatives thereof;oligonucleotides and/or derivatives thereof; paclitaxel and/orderivatives thereof; penicillin and/or derivatives thereof; pentamidineisethionate and/or derivatives thereof; phenindione and/or derivativesthereof; phenylbutazone and/or derivatives thereof; phosphodiesteraseinhibitors and/or derivatives thereof; plasminogen activator inhibitor-1and/or derivatives thereof; plasminogen activator inhibitor-2 and/orderivatives thereof; platelet factor 4 and/or derivatives thereof;platelet derived growth factor and/or derivatives thereof; plavix and/orderivatives thereof; Postmi 75 and/or derivatives thereof; prednisoneand/or derivatives thereof; prednisolone and/or derivatives thereof;probucol and/or derivatives thereof; progesterone and/or derivativesthereof, prostacyclin and/or derivatives thereof, prostaglandininhibitors and/or derivatives thereof, protamine and/or derivativesthereof, protease and/or derivatives thereof, protein kinase inhibitorsand/or derivatives thereof (e.g., staurosporin, etc.); quinine and/orderivatives thereof, radioactive agents and/or derivatives thereof(e.g., Cu-64, Ca-67, Cs-131, Ga-68, Zr-89, Ku-97, Tc-99m, Rh-105,Pd-103, Pd-109, In-111, I-123, I-125, I-131, Re-186, Re-188, Au-198,Au-199, Pb-203, At-211, Pb-212, Bi-212, H3P3204, etc.); rapamycin and/orderivatives thereof; receptor antagonists for histamine and/orderivatives thereof; refludan and/or derivatives thereof; retinoic acidsand/or derivatives thereof; revasc and/or derivatives thereof; rifamycinand/or derivatives thereof; sense or anti-sense oligonucleotides and/orderivatives thereof (e.g., DNA, RNA, plasmid DNA, plasmid RNA, etc.);seramin and/or derivatives thereof, steroids; seramin and/or derivativesthereof; serotonin and/or derivatives thereof; serotonin blockers and/orderivatives thereof; streptokinase and/or derivatives thereof;sulfasalazine and/or derivatives thereof; sulfonamides and/orderivatives thereof (e.g., sulfamethoxazole, etc.); sulphated chitinderivatives; sulphated polysaccharide peptidoglycan complex and/orderivatives thereof; TH1 and/or derivatives thereof (e.g.,Interleukins-2, -12, and -15, gamma interferon, etc.); thioproteseinhibitors and/or derivatives thereof; taxol and/or derivatives thereof(e.g., taxotere, baccatin, 10-deacetyltaxol, 7-xylosyl-10-deacetyltaxol,cephalomannine, 10-de acetyl-7-epitaxol, 7 epitaxol, 10-deacetylbaccatinIII, 10-deacetylcephaolmannine, etc.); ticlid and/or derivativesthereof, ticlopidine and/or derivatives thereof, tick anti-coagulantpeptide and/or derivatives thereof, thioprotese inhibitors and/orderivatives thereof; thyroid hormone and/or derivatives thereof; tissueinhibitor of metalloproteinase-1 and/or derivatives thereof; tissueinhibitor of metalloproteinase-2 and/or derivatives thereof, tissueplasma activators; TNF and/or derivatives thereof, tocopherol and/orderivatives thereof, toxins and/or derivatives thereof, tranilast and/orderivatives thereof, transforming growth factors alpha and beta and/orderivatives thereof; trapidil and/or derivatives thereof,triazolopyrimidine and/or derivatives thereof, vapiprost and/orderivatives thereof; vinblastine and/or derivatives thereof; vincristineand/or derivatives thereof; zidovudine and/or derivatives thereof. Ascan be appreciated, the agent can include one or more derivatives of theabove listed compounds and/or other compounds. In one non-limitingembodiment, the agent includes, but is not limited to, trapidil,trapidil derivatives, taxol, taxol derivatives (e.g., taxotere,baccatin, 10-deacetyltaxol, 7-xylosyl-10-deacetyltaxol, cephalomannine,10-deacetyl-7-epitaxol, 7 epitaxol, 10-deacetylbaccatin III,10-deacetylcephaolmannine, etc.), cytochalasin, cytochalasin derivatives(e.g., cytochalasin A, cytochalasin B, cytochalasin C, cytochalasin D,cytochalasin E, cytochalasin F, cytochalasin G, cytochalasin H,cytochalasin J, cytochalasin K, cytochalasin L, cytochalasin M,cytochalasin N, cytochalasin 0, cytochalasin P, cytochalasin Q,cytochalasin R, cytochalasin S, chaetoglobosin A, chaetoglobosin B,chaetoglobosin C, chaetoglobosin D, chaetoglobosin E, chaetoglobosin F,chaetoglobosin G, chaetoglobosin J, chaetoglobosin K, deoxaphomin,proxiphomin, protophomin, zygosporin D, zygosporin E, zygosporin F,zygosporin G, aspochalasin B, aspochalasin C, aspochalasin D, etc.),paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives,5-phenylmethimazole, 5-phenylmethimazole derivatives, GM-CSF(granulo-cytemacrophage colony-stimulating-factor), GM-CSF derivatives,statins or HMG-CoA reductase inhibitors forming a class of hypolipidemicagents, combinations, or analogs thereof; or combinations thereof. Thetype and/or amount of agent included in the device and/or coated on thedevice can vary. When two or more agents are included in and/or arecoated on the device, the amount of two or more agents can be the sameor different. The type and/or amount of agent included on, in, and/or inconjunction with the device are generally selected to address one ormore clinical events.

Typically, the amount of agent included on, in, and/or used inconjunction with the device is about 0.01-100 ug per mm2 and/or at leastabout 0.01 wt. % of device; however, other amounts can be used. In onenon-limiting embodiment of the invention, the device can be partially offully coated and/or impregnated with one or more agents to facilitate inthe success of a particular medical procedure. The amount of two of moreagents on, in, and/or used in conjunction with the device can be thesame or different. The one or more agents can be coated on and/orimpregnated in the device by a variety of mechanisms such as, but notlimited to, spraying (e.g., atomizing spray techniques, etc.), flamespray coating, powder deposition, dip coating, flow coating, dip-spincoating, roll coating (direct and reverse), sonication, brushing, plasmadeposition, depositing by vapor deposition, MEMS technology, androtating mold deposition. In another and/or alternative non-limitingembodiment of the invention, the type and/or amount of agent includedon, in, and/or in conjunction with the device is generally selected forthe treatment of one or more clinical events. Typically, the amount ofagent included on, in, and/or used in conjunction with the device isabout 0.01-100 ug per mm2 and/or at least about 0.01-100 wt. % of thedevice; however, other amounts can be used. The amount of two of moreagents on, in, and/or used in conjunction with the device can be thesame or different. As such, the medical device, when it includes,contains, and/or is coated with one or more agents, can include one ormore agents to address one or more medical needs. In one non-limitingembodiment of the invention, the medical device can be partially orfully coated with one or more agents and/or impregnated with one or moreagents to facilitate in the success of a particular medical procedure.The one or more agents can be coated on and/or impregnated in themedical device by a variety of mechanisms such as, but not limited to,spraying (e.g., atomizing spray techniques, etc.), dip coating, rollcoating, sonication, brushing, plasma deposition, depositing by vapordeposition. In another and/or alternative non-limiting embodiment of theinvention, the type and/or amount of agent included on, in, and/or inconjunction with the medical device is generally selected for thetreatment of one or more medical treatments. Typically, the amount ofagent included on, in, and/or used in conjunction with the medicaldevice is about 0.01-100 ug per mm2; however, other amounts can be used.The amount of two or more agents on, in, and/or used in conjunction withthe medical device can be the same or different.

In a further and/or alternative non-limiting aspect of the presentinvention, the one or more agents on and/or in the medical device, whenused on the medical device, can be released in a controlled manner sothe area in question to be treated is provided with the desired dosageof the agent over a sustained period of time. As can be appreciated,controlled release of one or more agents on the medical device is notalways required and/or desirable. As such, one or more of the agents onand/or in the medical device can be non-controllably released from themedical device during and/or after insertion of the medical device inthe treatment area. It can also be appreciated that one or more agentson and/or in the medical device can be controllably released from themedical device and one or more agents on and/or in the medical devicecan be non-controllably released from the medical device. It can also beappreciated that one or more agents on and/or in one region of themedical device can be controllably released from the medical device andone or more agents on and/or in the medical device can benon-controllably released from another region on the medical device. Assuch, the medical device can be designed such that 1) all the agent onand/or in the medical device is controllably released, 2) some of theagent on and/or in the medical device is controllably released and someof the agent on the medical device is non-controllably released, or 3)none of the agent on and/or in the medical device is controllablyreleased. The medical device can also be designed such that the rate ofrelease of the one or more agents from the medical device is the same ordifferent. The medical device can also be designed such that the rate ofrelease of the one or more agents from one or more regions on themedical device is the same or different. Non-limiting arrangements thatcan be used to control the release of one or more agents from themedical device include 1) at least partially coat one or more agentswith one or more polymers, 2) at least partially incorporate and/or atleast partially encapsulate one or more agents into and/or with one ormore polymers, and/or 3) insert one or more agents in pores, passageway,cavities, etc. in the medical device and at least partially coat orcover such pores, passageway, cavities, etc. with one or more polymers.As can be appreciated, other or additional arrangements can be used tocontrol the release of one or more agents from the medical device.

The one or more polymers used to at least partially control the releaseof one or more agent from the medical device can be porous ornon-porous. The one or more agents can be inserted into and/or appliedto one or more surface structures and/or micro-structures on the medicaldevice, and/or be used to at least partially form one or more surfacestructures and/or micro-structures on the medical device. As such, theone or more agents on the medical device can be 1) coated on one or moresurface regions of the medical device, 2) inserted and/or impregnated inone or more surface structures and/or micro-structures, etc. of themedical device, and/or 3) form at least a portion of or be included inat least a portion of the structure of the medical device. When the oneor more agents are coated on the medical device, the one or more agentscan 1) be directly coated on one or more surfaces of the medical device,2) be mixed with one or more coating polymers or other coating materialsand then at least partially coated on one or more surfaces of themedical device, 3) be at least partially coated on the surface ofanother coating material that has been at least partially coated on themedical device, and/or 4) be at least partially encapsulated between a)a surface or region of the medical device and one or more other coatingmaterials and/or b) two or more other coating materials.

As can be appreciated, many other coating arrangements can beadditionally or alternatively used. When the one or more agents areinserted and/or impregnated in one or more internal structures, surfacestructures and/or micro-structures of the medical device, 1) one or moreother coating materials can be applied at least partially over the oneor more internal structures, surface structures and/or micro-structuresof the medical device, and/or 2) one or more polymers can be combinedwith one or more agents. As such, the one or more agents can be 1)embedded in the structure of the medical device; 2) positioned in one ormore internal structures of the medical device; 3) encapsulated betweentwo polymer coatings; 4) encapsulated between the base structure and apolymer coating; 5) mixed in the base structure of the medical devicethat includes at least one polymer coating; or 6) one or morecombinations of 1, 2, 3, 4 and/or 5. In addition or alternatively, theone or more coating of the one or more polymers on the medical devicecan include 1) one or more coatings of non-porous polymers; 2) one ormore coatings of a combination of one or more porous polymers and one ormore non-porous polymers; 3) one or more coating of porous polymer, or4) one or more combinations of options 1, 2, and 3.

As can be appreciated, different agents can be located in and/or betweendifferent polymer coating layers and/or on the structure of the medicaldevice. As can also be appreciated, many other and/or additional coatingcombinations and/or configurations can be used. The concentration of oneor more agents, the type of polymer, the type and/or shape of internalstructures in the medical device and/or the coating thickness of the oneor more agents can be used to control the release time, the releaserate, and/or the dosage amount of one or more agents; however, other oradditional combinations can be used. As such, the agent and polymersystem combination and location on the medical device can be numerous.As can also be appreciated, one or more agents can be deposited on thetop surface of the medical device to provide an initial uncontrolledburst effect of the one or more agents prior to 1) the controlledrelease of the one or more agents through one or more layers of polymersystem that include one or more non-porous polymers and/or 2) theuncontrolled release of the one or more agents through one or morelayers of polymer system. The one or more agents and/or polymers can becoated on the medical device by a variety of mechanisms such as, but notlimited to, spraying (e.g., atomizing spray techniques, etc.), dipcoating, roll coating, sonication, brushing, plasma deposition, and/ordepositing by vapor deposition.

The thickness of each polymer layer and/or layer of agent is generallyat least about 0.01 gm and is generally less than about 150 μm. In onenon-limiting embodiment, the thickness of a polymer layer and/or layerof agent is about 0.02-75 μm, more particularly about 0.05-50 μm, andeven more particularly about 1-30 μm.

When the medical device includes and/or is coated with one or moreagents such that at least one of the agents is at least partiallycontrollably released from the medical device, the need or use ofbody-wide therapy for extended periods of time can be reduced oreliminated. In the past, the use of body-wide therapy was used by thepatient long after the patient left the hospital or other type ofmedical facility. This body-wide therapy could last days, weeks, monthsor sometimes over a year after surgery. The medical device of thepresent invention can be applied or inserted into a treatment areaand 1) merely requires reduced use and/or extended use of body-widetherapy after application or insertion of the medical device, or 2) doesnot require use and/or extended use of body-wide therapy afterapplication or insertion of the medical device. As can be appreciated,use and/or extended use of body-wide therapy can be used afterapplication or insertion of the medical device at the treatment area. Inone non-limiting example, no body-wide therapy is needed after theinsertion of the medical device into a patient. In another and/oralternative non-limiting example, short-term use of body-wide therapy isneeded or used after the insertion of the medical device into a patient.Such short-term use can be terminated after the release of the patientfrom the hospital or other type of medical facility, or one to two daysor weeks after the release of the patient from the hospital or othertype of medical facility; however, it will be appreciated that othertime periods of body-wide therapy can be used. As a result of the use ofthe medical device of the present invention, the use of body-widetherapy after a medical procedure involving the insertion of a medicaldevice into a treatment area can be significantly reduced or eliminated.

In another and/or alternative non-limiting aspect of the presentinvention, controlled release of one or more agents from the medicaldevice (when controlled release is desired) can be accomplished by usingone or more non-porous polymer layers; however, other and/or additionalmechanisms can be used to controllably release the one or more agents.The one or more agents are at least partially controllably released bymolecular diffusion through the one or more non-porous polymer layers.When one or more non-porous polymer layers are used, the one or morepolymer layers are typically biocompatible polymers; however, this isnot required. The one or more non-porous polymers can be applied to themedical device without the use of chemicals, solvents, and/or catalysts;however, this is not required. In one non-limiting example, thenon-porous polymer can be at least partially applied by, but is notlimited to, vapor deposition and/or plasma deposition. The non-porouspolymer can be selected so as to polymerize and cure merely uponcondensation from the vapor phase; however, this is not required. Theapplication of the one or more non-porous polymer layers can beaccomplished without increasing the temperature above ambienttemperature (e.g., 65-90° F.); however, this is not required. Thenon-porous polymer system can be mixed with one or more agents prior tobeing coated on the medical device and/or be coated on a medical devicethat previously included one or more agents; however, this is notrequired. The use or one or more non-porous polymer layers allows foraccurate controlled release of the agent from the medical device. Thecontrolled release of one or more agents through the non-porous polymeris at least partially controlled on a molecular level utilizing themotility of diffusion of the agent through the nonporous polymer. In onenon-limiting example, the one or more non-porous polymer layers caninclude, but are not limited to, polyamide, parylene (e.g., parylene C,parylene N) and/or a parylene derivative.

In still another and/or alternative non-limiting aspect of the presentinvention, controlled release of one or more agents from the medicaldevice (when controlled release is desired) can be accomplished by usingone or more polymers that form a chemical bond with one or more agents.In one non-limiting example, at least one agent includes trapidil,trapidil derivative or a salt thereof that is covalently bonded to atleast one polymer such as, but not limited to, an ethylene-acrylic acidcopolymer. The ethylene is the hydrophobic group and the acrylic acid isthe hydrophilic group. The mole ratio of the ethylene to the acrylicacid in the copolymer can be used to control the hydrophobicity of thepolymer. The degree of hydrophobicity of one or more polymers can alsobe used to control the release rate of one or more agents from the oneor more polymers. The amount of agent that can be loaded with one ormore polymers can be a function of the concentration of anionic groupsand/or cationic groups in the one or more polymer. For agents that areanionic, the concentration of agent that can be loaded on the one ormore polymers is generally a function of the concentration of cationicgroups (e.g. amine groups and the like) in the one or more polymers andthe fraction of these cationic groups that can ionically bind to theanionic form of the one or more agents. For agents that are cationic(e.g., trapidil, etc.), the concentration of agent that can be loaded onthe one or more polymers is generally a function of the concentration ofanionic groups (i.e., carboxylate groups, phosphate groups, sulfategroups, and/or other organic anionic groups) in the one or morepolymers, and the fraction of these anionic groups that can ionicallybind to the cationic form of the one or more agents. As such, theconcentration of one or more agents that can be bound to the one or morepolymers can be varied by controlling the amount of hydrophobic andhydrophilic monomer in the one or more polymers, by controlling theefficiency of salt formation between the agent, and/or theanionic/cationic groups in the one or more polymers.

In still another and/or alternative non-limiting aspect of the presentinvention, controlled release of one or more agents from the medicaldevice (when controlled release is desired) can be accomplished by usingone or more polymers that include one or more induced cross-links. Theseone or more cross-links can be used to at least partially control therate of release of the one or more agents from the one or more polymers.The cross-linking in the one or more polymers can be instituted by anumber to techniques such as, but not limited to, using catalysts,radiation, heat, and/or the like. The one or more cross-links formed inthe one or more polymers can result in the one or more agents becomingpartially or fully entrapped within the cross-linking, and/or form abond with the cross-linking. As such, the partially or fully entrappedagent takes longer to release itself from the cross-linking, therebydelaying the release rate of the one or more agents from the one or morepolymers. Consequently, the amount of agent, and/or the rate at whichthe agent is released from the medical device over time can be at leastpartially controlled by the amount or degree of cross-linking in the oneor more polymers.

In still a further and/or alternative aspect of the present invention, avariety of polymers can be coated on the medical device and/or be usedto form at least a portion of the medical device. The one or morepolymers can be used on the medical for a variety of reasons such as,but not limited to, 1) forming a portion of the medical device, 2)improving a physical property of the medical device (e.g., improvestrength, improve durability, improve biocompatibility, reduce friction,etc.), 3) forming a protective coating on one or more surface structureson the medical device, 4) at least partially forming one or more surfacestructures on the medical device, and/or 5) at least partiallycontrolling a release rate of one or more agents from the medicaldevice. As can be appreciated, the one or more polymers can have otheror additional uses on the medical device. The one or more polymers canbe porous, non-porous, biostable, biodegradable (i.e., dissolves,degrades, is absorbed, or any combination thereof in the body), and/orbiocompatible. When the medical device is coated with one or morepolymers, the polymer can include 1) one or more coatings of non-porouspolymers; 2) one or more coatings of a combination of one or more porouspolymers and one or more non-porous polymers; 3) one or more coatings ofone or more porous polymers and one or more coatings of one or morenon-porous polymers; 4) one or more coating of porous polymer, or 5) oneor more combinations of options 1, 2, 3 and 4. The thickness of the oneor more of the polymer layers can be the same or different. When one ormore layers of polymer are coated onto at least a portion of the medicaldevice, the one or more coatings can be applied by a variety oftechniques such as, but not limited to, vapor deposition and/or plasmadeposition, spraying, dip-coating, roll coating, sonication,atomization, brushing and/or the like; however, other or additionalcoating techniques can be used. The one or more polymers that can becoated on the medical device and/or used to at least partially form themedical device can be polymers that are considered to be biodegradable,bioresorbable, or bioerodable; polymers that are considered to bebiostable; and/or polymers that can be made to be biodegradable and/orbioresorbable with modification. Non-limiting examples of polymers thatare considered to be biodegradable, bioresorbable, or bioerodableinclude, but are not limited to, aliphatic polyesters; poly(glycolicacid) and/or copolymers thereof (e.g., poly(glycolide trimethylenecarbonate); poly(caprolactone glycolide)); poly(lactic acid) and/orisomers thereof (e.g., poly-L (lactic acid) and/or poly-D Lactic acid)and/or copolymers thereof (e.g. DL-PLA), with and without additives(e.g. calcium phosphate glass), and/or other copolymers (e.g.poly(caprolactone lactide), poly(lactide glycolide), poly(lactic acidethylene glycol)); poly(ethylene glycol); poly(ethylene glycol)diacrylate; poly(lactide); polyalkylene succinate; polybutylenediglycolate; polyhydroxybutyrate (PHB); polyhydroxyvalerate (PHV);polyhydroxybutyrate/polyhydroxyvalerate copolymer (PHB/PHV);poly(hydroxybutyrate-co-valerate); polyhydroxyalkaoates (PHA);polycaprolactone; poly (caprolactone-polyethylene glycol) copolymer;poly(valerolactone); polyanhydrides; poly(orthoesters) and/or blendswith polyanhydrides; poly(anhydride-co-imide); poly carbonates(aliphatic); poly(hydroxyl-esters); polydioxanone; polyanhydrides;polyanhydride esters; polycyanoacrylates; poly(alkyl 2-cyanoacrylates);poly(amino acids); poly(phosphazenes); poly(propylene fumarate);poly(propylene fumarate-co-ethylene glycol); poly(fumarate anhydrides);fibrinogen; fibrin; gelatin; cellulose and/or cellulose derivativesand/or cellulosic polymers (e.g., cellulose acetate, cellulose acetatebutyrate, cellulose butyrate, cellulose ethers, cellulose nitrate,cellulose propionate, cellophane); chitosan and/or chitosan derivatives(e.g., chitosan NOCC, chitosan NOOC-G); alginate; polysaccharides;starch; amylase; collagen; polycarboxylic acids; poly(ethylester-co-carboxylate carbonate) (and/or other tyrosine derived polycarbonates); poly(iminocarbonate); poly(BPA-iminocarbonate);poly(trimethylene carbonate); poly(iminocarbonate-amide) copolymersand/or other pseudo-poly(amino acids); poly(ethylene glycol);poly(ethylene oxide); poly(ethylene oxide)/poly(butylene terephthalate)copolymer; poly(epsilon-caprolactone-dimethyltrimethylene carbonate);poly(ester amide); poly(amino acids) and conventional synthetic polymersthereof; poly(alkylene oxalates); poly(alkylcarbonate); poly(adipicanhydride); nylon copolyamides; NO-carboxymethyl chitosan NOCC);carboxymethyl cellulose; copoly(ether-esters) (e.g., PEO/PLA dextrans);polyketals; biodegradable polyethers; biodegradable polyesters;polydihydropyrans; polydepsipeptides; polyarylates (L-tyrosine-derived)and/or free acid polyarylates; polyamides (e.g., nylon 6-6,polycaprolactam); poly(propylene fumarate-co-ethylene glycol) (e.g.,fumarate anhydrides); hyaluronates; poly-p-dioxanone; polypeptides andproteins; polyphosphoester; polyphosphoester urethane; polysaccharides;pseudo-poly(amino acids); starch; terpolymer; (copolymers of glycolide,lactide, or dimethyltrimethylene carbonate); rayon; rayon triacetate;latex; and/or copolymers, blends, and/or composites of above.Non-limiting examples of polymers that considered to be biostableinclude, but are not limited to, parylene; parylene c; parylene f;parylene n; parylene derivatives; maleic anyhydride polymers;phosphorylcholine; poly n-butyl methacrylate (PBMA);polyethylene-co-vinyl acetate (PEVA); PBMA/PEVA blend or copolymer;polytetrafluoroethene (Teflon®) and derivatives; poly-paraphenyleneterephthalamide (Kevlar®); poly (ether ketone) (PEEK); poly(styrene-b-isobutylene-b-styrene) (Translute™); tetramethyldisiloxane(side chain or copolymer); polyimides polysulfides; poly(ethyleneterephthalate); poly(methyl methacrylate); poly(ethylene-co-methylmethacrylate); styrene-ethylene/butylene-styrene block copolymers; ABS;SAN; acrylic polymers and/or copolymers (e.g., n-butyl-acrylate, n-butylmethacrylate, 2-ethylhexyl acrylate, lauryl-acrylate, 2-hydroxy-propylacrylate, polyhydroxyethyl, methacrylate/methylmethacrylate copolymers);glycosaminoglycans; alkyd resins; elastin; polyether sulfones; epoxyresin; poly(oxymethylene); polyolefins; polymers of silicone; polymersof methane; polyisobutylene; ethylene-alphaolefin copolymers;polyethylene; polyacrylonitrile; fluorosilicones; poly(propylene oxide);polyvinyl aromatics (e.g., polystyrene); poly(vinyl ethers) (e.g.polyvinyl methyl ether); poly(vinyl ketones); poly(vinylidene halides)(e.g., polyvinylidene fluoride, polyvinylidene chloride);poly(vinylpyrolidone); poly(vinylpyrolidone)/vinyl acetate copolymer;polyvinylpridine prolastin or silk-elastin polymers (SELP); silicone;silicone rubber; polyurethanes (polycarbonate polyurethanes, siliconeurethane polymer) (e.g., chronoflex varieties, bionate varieties); vinylhalide polymers and/or copolymers (e.g., polyvinyl chloride);polyacrylic acid; ethylene acrylic acid copolymer; ethylene vinylacetate copolymer; polyvinyl alcohol; poly(hydroxyl alkylmethacrylate);polyvinyl esters (e.g., polyvinyl acetate); and/or copolymers, blends,and/or composites of above. Non-limiting examples of polymers that canbe made to be biodegradable and/or bioresorbable with modificationinclude, but are not limited to, hyaluronic acid (hyanluron);polycarbonates; polyorthocarbonates; copolymers of vinyl monomers;polyacetals; biodegradable polyurethanes; polyacrylamide;polyisocyanates; polyamide; and/or copolymers, blends, and/or compositesof above. As can be appreciated, other and/or additional polymers and/orderivatives of one or more of the above listed polymers can be used. Theone or more polymers can be coated on the medical device by a variety ofmechanisms such as, but not limited to, spraying (e.g., atomizing spraytechniques, etc.), dip coating, roll coating, sonication, brushing,plasma deposition, and/or depositing by vapor deposition. The thicknessof each polymer layer is generally at least about 0.01 μm and isgenerally less than about 150 μm; however, other thicknesses can beused. In one non-limiting embodiment, the thickness of a polymer layerand/or layer of agent is about 0.02-75 μm, more particularly about0.05-50 μm, and even more particularly about 1-30 μm. As can beappreciated, other thicknesses can be used. In one non-limitingembodiment, the medical device includes and/or is coated with parylene,PLGA, POE, PGA, PLLA, PAA, PEG, chitosan and/or derivatives of one ormore of these polymers. In another and/or alternative non-limitingembodiment, the medical device includes and/or is coated with anon-porous polymer that includes, but is not limited to, polyamide,Parylene C, Parylene N and/or a parylene derivative. In still anotherand/or alternative non-limiting embodiment, the medical device includesand/or is coated with poly (ethylene oxide), poly(ethylene glycol), andpoly(propylene oxide), polymers of silicone, methane, tetrafluoroethylene (including TEFLON® brand polymers), tetramethyldisiloxane, andthe like.

In another and/or alternative non-limiting aspect of the presentinvention, the medical device, when including and/or is coated with oneor more agents, can include and/or can be coated with one or more agentsthat are the same or different in different regions of the medicaldevice and/or have differing amounts and/or concentrations in differingregions of the medical device. For instance, the medical device can 1)be coated with and/or include one or more biologicals on at least oneportion of the medical device and at least another portion of themedical device is not coated with and/or includes one or more agents; 2)be coated with and/or include one or more biologicals on at least oneportion of the medical device that is different from one or morebiologicals on at least another portion of the medical device; 3) becoated with and/or include one or more biologicals at a concentration onat least one portion of the medical device that is different from theconcentration of one or more biologicals on at least another portion ofthe medical device; etc.

In still another and/or alternative non-limiting aspect of the presentinvention, one or more surfaces of the medical device can be treated toachieve the desired coating properties of the one or more agents and oneor more polymers coated on the medical device. Such surface treatmenttechniques include, but are not limited to, cleaning, buffing,smoothing, etching (chemical etching, plasma etching, etc.), etc. Whenan etching process is used, various gasses can be used for such asurface treatment process such as, but not limited to, carbon dioxide,nitrogen, oxygen, Freon®, helium, hydrogen, etc. The plasma etchingprocess can be used to clean the surface of the medical device, changethe surface properties of the medical device so as to affect theadhesion properties, lubricity properties, etc. of the surface of themedical device. As can be appreciated, other or additional surfacetreatment processes can be used prior to the coating of one or moreagents and/or polymers on the surface of the medical device. In onenon-limiting manufacturing process, one or more portions of the medicaldevice are cleaned and/or plasma etched; however, this is not required.Plasma etching can be used to clean the surface of the medical device,and/or to form one or more non-smooth surfaces on the medical device tofacilitate in the adhesion of one or more coatings of agents and/or oneor more coatings of polymer on the medical device. The gas for theplasma etching can include carbon dioxide and/or other gasses. Once oneor more surface regions of the medical device have been treated, one ormore coatings of polymer and/or agent can be applied to one or moreregions of the medical device. For example, 1) one or more layers ofporous or non-porous polymer can be coated on an outer and/or innersurface of the medical device, 2) one or more layers of agent can becoated on an outer and/or inner surface of the medical device, or 3) oneor more layers of porous or non-porous polymer that includes one or moreagents can be coated on an outer and/or inner surface of the medicaldevice. The one or more layers of agent can be applied to the medicaldevice by a variety of techniques (e.g., dipping, rolling, brushing,spraying, particle atomization, etc.). One non-limiting coatingtechnique is by an ultrasonic mist coating process wherein ultrasonicwaves are used to break up the droplet of agent and form a mist of veryfine droplets. These fine droplets have an average droplet diameter ofabout 0.1-3 microns. The fine droplet mist facilitates in the formationof a uniform coating thickness and can increase the coverage area on themedical device.

In still yet another and/or alternative non-limiting aspect of thepresent invention, one or more portions of the medical device can 1)include the same or different agents, 2) include the same or differentamount of one or more agents, 3) include the same or different polymercoatings, 4) include the same or different coating thicknesses of one ormore polymer coatings, 5) have one or more portions of the medicaldevice controllably release and/or uncontrollably release one or moreagents, and/or 6) have one or more portions of the medical devicecontrollably release one or more agents and one or more portions of themedical device uncontrollably release one or more agents.

In yet another and/or alternative non-limiting aspect of the invention,the medical device can include a marker material that facilitatesenabling the medical device to be properly positioned in a bodypassageway. The marker material is typically designed to be visible toelectromagnetic waves (e.g., x-rays, microwaves, visible light, infraredwaves, ultraviolet waves, etc.); sound waves (e.g., ultrasound waves,etc.); magnetic waves (e.g., MRI, etc.); and/or other types ofelectromagnetic waves (e.g., microwaves, visible light, infrared waves,ultraviolet waves, etc.). In one non-limiting embodiment, the markermaterial is visible to x-rays (i.e., radiopaque). The marker materialcan form all or a portion of the medical device and/or be coated on oneor more portions (flaring portion and/or body portion, at ends ofmedical device, at or near transition of body portion and flaringsection, etc.) of the medical device. The location of the markermaterial can be on one or multiple locations on the medical device. Thesize of the one or more regions that include the marker material can bethe same or different. The marker material can be spaced at defineddistances from one another so as to form ruler-like markings on themedical device to facilitate in the positioning of the medical device ina body passageway. The marker material can be a rigid or flexiblematerial. The marker material can be a biostable or biodegradablematerial. When the marker material is a rigid material, the markermaterial is typically formed of a metal material (e.g., metal band,metal plating, etc.); however, other or additional materials can beused. The metal, which at least partially forms the medical device, canfunction as a marker material; however, this is not required. When themarker material is a flexible material, the marker material typically isformed of one or more polymers that are marker materialsin-of-themselves and/or include one or more metal powders and/or metalcompounds. In one non-limiting embodiment, the flexible marker materialincludes one or more metal powders in combinations with parylene, PLGA,POE, PGA, PLLA, PAA, PEG, chitosan and/or derivatives of one or more ofthese polymers. In another and/or alternative non-limiting embodiment,the flexible marker material includes one or more metals and/or metalpowders of aluminum, barium, bismuth, cobalt, copper, chromium, gold,iron, stainless steel, titanium, vanadium, nickel, zirconium, niobium,lead, molybdenum, platinum, yttrium, calcium, rare earth metals,rhenium, zinc, silver, depleted radioactive elements, tantalum and/ortungsten; and/or compounds thereof. The marker material can be coatedwith a polymer protective material; however, this is not required. Whenthe marker material is coated with a polymer protective material, thepolymer coating can be used to 1) at least partially insulate the markermaterial from body fluids, 2) facilitate in retaining the markermaterial on the medical device, 3) at least partially shield the markermaterial from damage during a medical procedure and/or 4) provide adesired surface profile on the medical device. As can be appreciated,the polymer coating can have other or additional uses. The polymerprotective coating can be a biostable polymer or a biodegradable polymer(e.g., degrades and/or is absorbed). The coating thickness of theprotective coating polymer material (when used) is typically less thanabout 300 microns; however, other thickness can be used. In onenon-limiting embodiment, the protective coating materials includeparylene, PLGA, POE, PGA, PLLA, PAA, PEG, chitosan and/or derivatives ofone or more of these polymers.

In a further and/or alternative non-limiting aspect of the presentinvention, the medical device or one or more regions of the medicaldevice can be constructed by use of one or more microelectromechanicalmanufacturing (MEMS) techniques (e.g., micro-machining, lasermicro-machining, laser micro-machining, micro-molding, etc.); however,other or additional manufacturing techniques can be used.

The medical device can include one or more surface structures (e.g.,pore, channel, pit, rib, slot, notch, bump, teeth, needle, well, hole,groove, etc.). These structures can be at least partially formed by MEMS(e.g., micro-machining, etc.) technology and/or other types oftechnology.

The medical device can include one or more micro-structures (e.g.,micro-needle, micro-pore, micro-cylinder, micro-cone, micro-pyramid,micro-tube, micro-parallelopiped, micro-prism, micro-hemisphere, teeth,rib, ridge, ratchet, hinge, zipper, zip-tie like structure, etc.) on thesurface of the medical device. As defined herein, a micro-structure is astructure that has at least one dimension (e.g., average width, averagediameter, average height, average length, average depth, etc.) that isno more than about 2 mm, and typically no more than about 1 mm. As canbe appreciated, the medical device, when including one or more surfacestructures, 1) all the surface structures can be micro-structures, 2)all the surface structures can be non-micro-structures, or 3) a portionof the surface structures can be micro-structures and a portion can benon-micro-structures. Non-limiting examples of structures that can beformed on the medical devices are illustrated in United States PatentPublication Nos. 2004/0093076 and 2004/0093077, which are incorporatedherein by reference. Typically, the micro-structures, when formed,extend from or into the outer surface no more than about 400 microns,and more typically less than about 300 microns, and more typically about15-250 microns; however, other sizes can be used. The micro-structurescan be clustered together or disbursed throughout the surface of themedical device. Similar shaped and/or sized micro-structures and/orsurface structures can be used, or different shaped and/or sizedmicro-structures can be used. When one or more surface structures and/ormicro-structures are designed to extend from the surface of the medicaldevice, the one or more surface structures and/or micro-structures canbe formed in the extended position and/or be designed so as to extendfrom the medical device during and/or after deployment of the medicaldevice in a treatment area. The micro-structures and/or surfacestructures can be designed to contain and/or be fluidly connected to apassageway, cavity, etc.; however, this is not required. The one or moresurface structures and/or micro-structures can be used to engage and/orpenetrate surrounding tissue or organs once the medical device has beenpositioned on and/or in a patient; however, this is not required. Theone or more surface structures and/or micro-structures can be used tofacilitate in forming and maintaining a shape of a medical device (i.e.,see devices in United States Patent Publication Nos. 2004/0093076 and2004/0093077). The one or more surface structures and/ormicro-structures can be at least partially formed by MEMS (e.g.,micro-machining, laser micro-machining, micro-molding, etc.) technology;however, this is not required. In one non-limiting embodiment, the oneor more surface structures and/or micro-structures can be at leastpartially formed of an agent and/or be formed of a polymer. One or moreof the surface structures and/or micro-structures can include one ormore internal passageways that can include one or more materials (e.g.,agent, polymer, etc.); however, this is not required. The one or moresurface structures and/or micro-structures can be formed by a variety ofprocesses (e.g., machining, chemical modifications, chemical reactions,MEMS (e.g., micro-machining, etc.), etching, laser cutting, etc.). Theone or more coatings and/or one or more surface structures and/ormicro-structures of the medical device can be used for a variety ofpurposes such as, but not limited to, 1) increasing the bonding and/oradhesion of one or more agents, adhesives, marker materials and/orpolymers to the medical device, 2) changing the appearance or surfacecharacteristics of the medical device, and/or 3) controlling the releaserate of one or more agents. The one or more micro-structures and/orsurface structures can be biostable, biodegradable, etc. One or moreregions of the medical device that are at least partially formed by MEMStechniques can be biostable, biodegradable, etc. The medical device orone or more regions of the medical device can be at least partiallycovered and/or filled with a protective material so to at leastpartially protect one or more regions of the medical device, and/or oneor more micro-structures and/or surface structures on the medical devicefrom damage.

One or more regions of the medical device, and/or one or moremicro-structures and/or surface structures on the medical device can bedamaged when the medical device 1) is packaged and/or stored, 2) isunpackaged, 3) is connected to and/or otherwise secured to and/or placedon another medical device, 4) is inserted into a treatment area, 5) ishandled by a user, and/or 6) a sheath is positioned on and/or removedfrom the medical device. As can be appreciated, the medical device canbe damaged in other or additional ways. The protective material can beused to protect the medical device and one or more micro-structuresand/or surface structures from such damage. The protective material caninclude one or more polymers previously identified above. The protectivematerial can be 1) biostable and/or biodegradable and/or 2) porousand/or non-porous.

In one non-limiting design, the polymer is at least partiallybiodegradable so as to at least partially expose one or moremicro-structure and/or surface structure to the environment after themedical device has been at least partially inserted into a treatmentarea. In another and/or additional non-limiting design, the protectivematerial includes, but is not limited to, sugar (e.g., glucose,fructose, sucrose, etc.), carbohydrate compound, salt (e.g., NaCl,etc.), parylene, PLGA, POE, PGA, PLLA, PAA, PEG, chitosan and/orderivatives of one or more of these materials; however, other and/oradditional materials can be used. In still another and/or additionalnon-limiting design, the thickness of the protective material isgenerally less than about 300 microns, and typically less than about 150microns; however, other thicknesses can be used. The protective materialcan be coated by one or more mechanisms previously described herein.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the medical device can include and/or be used with aphysical hindrance. The physical hindrance can include, but is notlimited to, an adhesive, sheath, magnet, tape, wire, string, etc. Thephysical hindrance can be used to 1) physically retain one or moreregions of the medical device in a particular form or profile, 2)physically retain the medical device on a particular deployment device,3) protect one or more surface structures and/or micro-structures on themedical device, and/or 4) form a barrier between one or more surfaceregions, surface structures and/or micro-structures on the medicaldevice and the fluids in a body passageway. As can be appreciated, thephysical hindrance can have other and/or additional functions. Thephysical hindrance is typically a biodegradable material; however, abiostable material can be used. The physical hindrance can be designedto withstand sterilization of the medical device; however, this is notrequired. The physical hindrance can be applied to, included in and/orbe used in conjunction with one or more medical devices. Additionally oralternatively, the physical hindrance can be designed to be used withand/or in conjunction with a medical device for a limited period of timeand then 1) disengage from the medical device after the medical devicehas been partially or fully deployed and/or 2) dissolve and/or degradeduring and/or after the medical device has been partially or fullydeployed; however, this is not required. Additionally or alternatively,the physical hindrance can be designed and be formulated to betemporarily used with a medical device to facilitate in the deploymentof the medical device; however, this is not required. In onenon-limiting use of the physical hindrance, the physical hindrance isdesigned or formulated to at least partially secure a medical device toanother device that is used to at least partially transport the medicaldevice to a location for treatment. In another and/or alternativenon-limiting use of the physical hindrance, the physical hindrance isdesigned or formulated to at least partially maintain the medical devicein a particular shape or form until the medical device is at leastpartially positioned in a treatment location. In still another and/oralternative non-limiting use of the physical hindrance, the physicalhindrance is designed or formulated to at least partially maintainand/or secure one type of medical device to another type of medicalinstrument or device until the medical device is at least partiallypositioned in a treatment location. The physical hindrance can also oralternatively be designed and formulated to be used with a medicaldevice to facilitate in the use of the medical device. In onenon-limiting use, the physical hindrance, when in the form of anadhesive, can be formulated to at least partially secure a medicaldevice to a treatment area so as to facilitate in maintaining themedical device at the treatment area. For example, the physicalhindrance can be used in such use to facilitate in maintaining a medicaldevice on or at a treatment area until the medical device is properlysecured to the treatment area by sutures, stitches, screws, nails, rod,etc.; however, this is not required. Additionally or alternatively, thephysical hindrance can be used to facilitate in maintaining a medicaldevice on or at a treatment area until the medical device has partiallyor fully accomplished its objective. The physical hindrance is typicallya biocompatible material so as to not cause unanticipated adverseeffects when properly used. The physical hindrance can be biostable orbiodegradable (e.g., degrades and/or is absorbed, etc.). When thephysical hindrance includes or has one or more adhesives, the one ormore adhesives can be applied to the medical device by, but is notlimited to, spraying (e.g., atomizing spray techniques, etc.), dipcoating, roll coating, sonication, brushing, plasma deposition, and/ordepositing by vapor deposition, brushing, painting, etc.) on the medicaldevice. The physical hindrance can also or alternatively form at least apart of the medical device. One or more regions and/or surfaces of amedical device can also or alternatively include the physical hindrance.The physical hindrance can include one or more biological agents and/orother materials (e.g., marker material, polymer, etc.); however, this isnot required. When the physical hindrance is or includes an adhesive,the adhesive can be formulated to controllably release one or morebiological agents in the adhesive and/or be coated on and/or containedwithin the medical device; however, this is not required. The adhesivecan also or alternatively control the release of one or more biologicalagents located on and/or contained in the medical device by forming apenetrable or non-penetrable barrier to such biological agents; however,this is not required. The adhesive can include and/or be mixed with oneor more polymers; however, this is not required. The one or morepolymers can be used to 1) control the time of adhesion provided by saidadhesive, 2) control the rate of degradation of the adhesive, and/or 3)control the rate of release of one or more biological agents from theadhesive and/or diffusing or penetrating through the adhesive layer;however, this is not required. When the physical hindrance includes asheath, the sheath can be designed to partially or fully encircle themedical device. The sheath can be designed to be physically removed fromthe medical device after the medical device is deployed to a treatmentarea; however, this is not required. The sheath can be formed of abiodegradable material that at least partially degrades over time to atleast partially expose one or more surface regions, microstructuresand/or surface structures of the medical device; however, this is notrequired. The sheath can include and/or be at least be partially coatedwith one or more biological agents. The sheath includes one or morepolymers; however, this is not required. The one or more polymers can beused for a variety of reasons such as, but not limited to, 1) forming aportion of the sheath, 2) improving a physical property of the sheath(e.g., improve strength, improve durability, improve biocompatibility,reduce friction, etc.), and/or 3 at least partially controlling arelease rate of one or more biological agents from the sheath. As can beappreciated, the one or more polymers can have other or additional useson the sheath.

In still another and/or alternative aspect of the invention, the medicaldevice can be an expandable device that can be expanded by use of someother device (e.g., balloon, etc.) and/or is self-expanding. Theexpandable medical device can be fabricated from a material that has noor substantially no shape-memory characteristics or can be partiallyfabricated from a material having shape-memory characteristics.Typically, when one or more shape-memory materials are used, theshape-memory material composition is selected such that the shape-memorymaterial remains in an unexpanded configuration at a cold temperature(e.g., below body temperature); however, this is not required. When theshape-memory material is heated (e.g., to body temperature) theexpandable body section can be designed to expand to at least partiallyseal and secure the medical device in a body passageway or other region;however, this is not required.

In still another and/or alternative non-limiting aspect of theinvention, the medical device can be used in conjunction with one ormore other biological agents that are not on the medical device. Forinstance, the success of the medical device can be improved by infusing,injecting or consuming orally one or more biological agents. Suchbiological agents can be the same and/or different from the one or morebiological agents on and/or in the medical device. Such use of one ormore biological agents is commonly used in systemic treatment of apatient after a medical procedure (such as body-wide therapy), after themedical device has been inserted in the treatment area. Although themedical device of the present invention can be designed to reduce oreliminate the need for long periods of body-wide therapy after themedical device has been inserted in the treatment area, the use of oneor more biological agents can be used in conjunction with the medicaldevice to enhance the success of the medical device and/or reduce orprevent the occurrence of one or more biological problems (e.g.,infection, rejection of the medical device, etc.). For instance, soliddosage forms of biological agents for oral administration, and/or forother types of administration (e.g., suppositories, etc.) can be used.Such solid forms can include, but are not limited to, capsules, tablets,effervescent tablets, chewable tablets, pills, powders, sachets,granules and gels. The solid form of the capsules, tablets, effervescenttablets, chewable tablets, pills, etc. can have a variety of shapes suchas, but not limited to, spherical, cubical, cylindrical, pyramidal, andthe like. In such solid dosage form, one or more biological agents canbe admixed with at least one filler material such as, but not limitedto, sucrose, lactose or starch; however, this is not required. Suchdosage forms can include additional substances such as, but not limitedto, inert diluents (e.g., lubricating agents, etc.). When capsules,tablets, effervescent tablets or pills are used, the dosage form canalso include buffering agents; however, this is not required. Softgelatin capsules can be prepared to contain a mixture of the one or morebiological agents in combination with vegetable oil or other types ofoil; however, this is not required. Hard gelatin capsules can containgranules of the one or more biological agents in combination with asolid carrier such as, but not limited to, lactose, potato starch, cornstarch, cellulose derivatives of gelatin, etc.; however, this is notrequired. Tablets and pills can be prepared with enteric coatings foradditional time release characteristics; however, this is not required.Liquid dosage forms of the one or more biological agents for oraladministration can include pharmaceutically acceptable emulsions,solutions, suspensions, syrups, elixirs, etc.; however, this is notrequired. In one non-limiting embodiment, when at least a portion of oneor more biological agents is inserted into a treatment area (e.g., gelform, paste form, etc.) and/or provided orally (e.g., pill, capsule,etc.) and/or anally (suppository, etc.), one or more of the biologicalagents can be controllably released; however, this is not required. Inone non-limiting example, one or more biological agents can be given toa patient in solid dosage form and one or more of such biological agentscan be controllably released from such solid dosage forms. In anotherand/or alternative non-limiting example trapidil, trapidil derivatives,taxol, taxol derivatives, cytochalasin, cytochalasin derivatives,paclitaxel, paclitaxel derivatives, rapamycin, rapamycin derivatives,5-phenylmethimazole, 5-phenylmethimazole derivatives, GM-CSF, GM-CSFderivatives, or combinations thereof are given to a patient prior to,during and/or after the insertion of the medical device in a treatmentarea. As can be appreciated, other or additional biological agents canbe used.

Certain types of biological agents may be desirable to be present in atreated area for an extended period of time in order to utilize the fullor nearly full clinical potential the biological agent. For instance,trapidil and/or trapidil derivatives is a compound that has manyclinical attributes including, but not limited to, anti-plateleteffects, inhibition of smooth muscle cells and monocytes, fibroblastproliferation and increased MAPK-1 which in turn deactivates kinase, avasodilator, etc. These attributes can be effective in improving thesuccess of a medical device that has been inserted at a treatment area.In some situations, these positive effects of trapidil and/or trapidilderivatives need to be prolonged in a treatment area in order to achievecomplete clinical competency. Trapidil and/or trapidil derivatives havea half-life in vivo of about 2-4 hours with hepatic clearance of 48hours. In order to utilize the full clinical potential of trapidiland/or trapidil derivatives, trapidil and/or trapidil derivatives shouldbe metabolized over an extended period of time without interruption;however, this is not required. By inserting trapidil and/or trapidilderivatives in a solid dosage form, the trapidil and/or trapidilderivatives could be released in a patient over extended periods of timein a controlled manner to achieve complete or nearly complete clinicalcompetency of the trapidil and/or trapidil derivatives.

In another and/or alternative non-limiting example, one or morebiological agents are at least partially encapsulated in one or morepolymers. The one or more polymers can be biodegradable,non-biodegradable, porous, and/or non-porous. When the one or morepolymers are biodegradable, the rate of degradation of the one or morebiodegradable polymers can be used to at least partially control therate at which one or more biological agents are released into a bodypassageway and/or other parts of the body over time. The one or morebiological agents can be at least partially encapsulated with differentpolymer coating thickness, different numbers of coating layers, and/orwith different polymers to alter the rate at which one or morebiological agents are released in a body passageway and/or other partsof the body over time. The rate of degradation of the polymer isprincipally a function of the 1) water permeability and solubility ofthe polymer, 2) chemical composition of the polymer and/or biologicalagent, 3) mechanism of hydrolysis of the polymer, 4) biological agentencapsulated in the polymer, 5) size, shape and surface volume of thepolymer, 6) porosity of the polymer, 7) molecular weight of the polymer,8) degree of cross-linking in the polymer, 9) degree of chemical bondingbetween the polymer and biological agent, and/or 10) structure of thepolymer and/or biological agent. As can be appreciated, other factorsmay also affect the rate of degradation of the polymer. When the one ormore polymers are biostable, the rate at when the one or more biologicalagents are released from the biostable polymer is a function of the 1)porosity of the polymer, 2) molecular diffusion rate of the biologicalagent through the polymer, 3) degree of cross-linking in the polymer, 4)degree of chemical bonding between the polymer and biological agent, 5)chemical composition of the polymer and/or biological agent, 6)biological agent encapsulated in the polymer, 7) size, shape and surfacevolume of the polymer, and/or 8) structure of the polymer and/orbiological agent. As can be appreciated, other factors may also affectthe rate of release of the one or more biological agents from thebiostable polymer. Many different polymers can be used such as, but notlimited to, aliphatic polyester compounds (e.g., PLA (i.e., poly (D,L-lactic acid), poly (L-lactic acid)), PLGA (i.e. poly(lactide-co-glycoside), etc.), POE, PEG, PLLA, parylene, chitosan and/orderivatives thereof. As can be appreciated, the at least partiallyencapsulated biological agent can be introduced into a patient by meansother than by oral introduction, such as, but not limited to, injection,topical applications, intravenously, eye drops, nasal spray, surgicalinsertion, suppositories, intrarticularly, intraocularly, intranasally,intradermally, sublingually, intravesically, intrathecally,intraperitoneally, intracranially, intramuscularly, subcutaneously,directly at a particular site, and the like.

In a further and/or alternative non-limiting aspect of the presentinvention, the novel alloy used to at least partially form the medicaldevice is initially formed into a blank, a rod, a tube, etc. and thenfinished into final form by one or more finishing processes. The metalalloy blank, rod, tube, etc. can be formed by various techniques suchas, but not limited to, 1) melting the metal alloy and/or metals thatform the metal alloy (e.g., vacuum arc melting, etc.) and then extrudingand/or casting the metal alloy into a blank, rod, tube, etc., 2) meltingthe metal alloy and/or metals that form the metal alloy, forming a metalstrip and then rolling and welding the strip into a blank, rod, tube,etc., or 3) consolidating metal power of the metal alloy and/or metalpowder of metals that form the metal alloy into a blank, rod, tube, etc.When the metal alloy is formed into a blank, the shape and size of theblank is non-limiting. When the metal alloy is formed into a rod ortube, the rod or tube generally has a length of about 48 inches or less;however, longer lengths can be formed. In one non-limiting arrangement,the length of the rod or tube is about 8-20 inches. The average outerdiameter of the rod or tube is generally less than about 2 inches (i.e.,less than about 3.14 sq. in. cross-sectional area), more typically lessthan about 1 inch outer diameter, and even more typically no more thanabout 0.5 inch outer diameter; however, larger rod or tube diametersizes can be formed. In one non-limiting configuration for a tube, thetube has an inner diameter of about 0.31 inch plus or minus about 0.002inch and an outer diameter of about 0.5 inch plus or minus about 0.002inch. The wall thickness of the tube is about 0.095 inch plus or minusabout 0.002 inch. As can be appreciated, this is just one example ofmany different sized tubes that can be formed. In one non-limitingprocess, the blank, rod, tube, etc. can be formed from one or moreingots of metal or metal alloy. In one non-limiting process, an arcmelting process (e.g., vacuum arc melting process, etc.) can be used toform the blank, rod, tube, etc. In another non-limiting process, thenovel alloy powders can be placed in a crucible (e.g., silica crucible,etc.) and heated under a controlled atmosphere (e.g., vacuumenvironment, carbon monoxide environment, hydrogen and argonenvironment, helium, argon, etc.) by an induction melting furnace toform the blank, rod, tube, etc. As can be appreciated, other metalparticles can be used to form other metal alloys. It can be appreciatedthat other or additional processes can be used to form the blank, rod,tube, etc. When a tube of metal alloy is to be formed, a close-fittingrod can be used during the extrusion process to form the tube; however,this is not required. In another and/or additional non-limiting process,the tube of the metal alloy can be formed from a strip or sheet of metalalloy. The strip or sheet of metal alloy can be formed into a tube byrolling the edges of the sheet or strip and then welding together theedges of the sheet or strip. The welding of the edges of the sheet orstrip can be accomplished in several ways such as, but not limited to,a) holding the edges together and then e-beam welding the edges togetherin a vacuum, b) positioning a thin strip of metal alloy above and/orbelow the edges of the rolled strip or sheet to be welded, then weldingthe one or more strips along the rolled strip or sheet edges, and thengrinding off the outer strip, or c) laser welding the edges of therolled sheet or strip in a vacuum, oxygen reducing atmosphere, or inertatmosphere. In still another and/or additional non-limiting process, theblank, rod, tube, etc. of the metal alloy is formed by consolidatingmetal powder. In this process, fine particles of the novel alloy powdersalong with any additives are mixed to form a homogenous blend ofparticles. As can be appreciated, other metal particles can be used toform other metal alloys. Typically, the average particle size of themetal powders is less than about 200 mesh (e.g., less than 74 microns).A larger average particle size can interfere with the proper mixing ofthe metal powders and/or adversely affect one or more physicalproperties of the blank, rod, tube, etc. formed from the metal powders.In one non-limiting embodiment, the average particle size of the metalpowders is less than about 230 mesh (e.g., less than 63 microns). Inanother and/or alternative non-limiting embodiment, the average particlesize of the metal powders is about 2-63 microns, and more particularlyabout 5-40 microns. As can be appreciated, smaller average particlesizes can be used. The purity of the metal powders should be selected sothat the metal powders contain very low levels of carbon, oxygen andnitrogen. Typically, metal powder having a purity grade of at least 99.9and more typically at least about 99.95 should be used to obtain thedesired purity of the powders of the novel alloy. The blend of metalpowder is then pressed together to form a solid solution of the metalalloy into blank, rod, tube, etc. Typically, the pressing process is byan isostatic process (i.e., uniform pressure applied from all sides onthe metal powder); however other processes can be used. When the metalpowders are pressed together isostatically, cold isostatic pressing(CIP) is typically used to consolidate the metal powders; however, thisis not required. The pressing process can be performed in an inertatmosphere, an oxygen reducing atmosphere (e.g., hydrogen, argon andhydrogen mixture, etc.) and/or under a vacuum; however, this is notrequired. The average density of the blank, rod, tube, etc. that isachieved by pressing together the metal powders is about 80-90% of thefinal average density of the blank, rod, tube, etc. or about 70-96% theminimum theoretical density of the metal alloy. Pressing pressures of atleast about 300 MPa are generally used. Generally, the pressing pressureis about 400-700 MPa; however, other pressures can be used. After themetal powders are pressed together, the pressed metal powders aresintered at high temperature (e.g., 2000-3000° C.) to fuse the metalpowders together to form the blank, rod, tube, etc. The sintering of theconsolidated metal powder can be performed in an oxygen reducingatmosphere (e.g., helium, argon, hydrogen, argon and hydrogen mixture,etc.) and/or under a vacuum; however, this is not required. At the highsintering temperatures, a high hydrogen atmosphere will reduce both theamount of carbon and oxygen in the formed blank, rod, tube, etc. Thesintered metal powder generally has an as-sintered average density ofabout 90-99% the minimum theoretical density of the metal alloy.Typically, the sintered blank, rod, tube, etc. has a final averagedensity of at least about 8 gm/cc, and typically at least about 8.3gm/cc, and can be up to or greater than about 16 gm/cc. The density ofthe formed blank, rod, tube, etc. will generally depend on the type ofmetal alloy sued to form the blank, rod, tube, etc.

In still a further and/or alternative non-limiting aspect of the presentinvention, when a solid rod of the metal alloy is formed, the rod isthen formed into a tube prior to reducing the outer cross-sectional areaor diameter of the rod. The rod can be formed into a tube by a varietyof processes such as, but not limited to, cutting or drilling (e.g., gundrilling, etc.) or by cutting (e.g., EDM, etc.). The cavity orpassageway formed in the rod typically is formed fully through the rod;however, this is not required.

In yet a further and/or alternative non-limiting aspect of the presentinvention, the blank, rod, tube, etc. can be cleaned and/or polishedafter the blank, rod, tube, etc. has been formed; however, this is notrequired. Typically, the blank, rod, tube, etc. is cleaned and/orpolished prior to being further processed; however, this is notrequired. When a rod of the metal alloy is formed into a tube, theformed tube is typically cleaned and/or polished prior to being furtherprocessed; however, this is not required. When the blank, rod, tube,etc. is resized and/or annealed, the resized and/or annealed blank, rod,tube, etc. is typically cleaned and/or polished prior to and/or aftereach or after a series of resizing and/or annealing processes; however,this is not required. The cleaning and/or polishing of the blank, rod,tube, etc. is used to remove impurities and/or contaminants from thesurfaces of the blank, rod, tube, etc. Impurities and contaminants canbecome incorporated into the metal alloy during the processing of theblank, rod, tube, etc. The inadvertent incorporation of impurities andcontaminants in the blank, rod, tube, etc. can result in an undesiredamount of carbon, nitrogen and/or oxygen, and/or other impurities in themetal alloy. The inclusion of impurities and contaminants in the metalalloy can result in premature micro-cracking of the metal alloy and/oran adverse effect on one or more physical properties of the metal alloy(e.g., decrease in tensile elongation, increased ductility, increasedbrittleness, etc.). The cleaning of the metal alloy can be accomplishedby a variety of techniques such as, but not limited to, 1) using asolvent (e.g., acetone, methyl alcohol, etc.) and wiping the metal alloywith a Kimwipe or other appropriate towel, 2) by at least partiallydipping or immersing the metal alloy in a solvent and thenultrasonically cleaning the metal alloy, and/or 3) by at least partiallydipping or immersing the metal alloy in a pickling solution. As can beappreciated, the metal alloy can be cleaned in other or additional ways.If the metal alloy is to be polished, the metal alloy is generallypolished by use of a polishing solution that typically includes an acidsolution; however, this is not required. In one non-limiting example,the polishing solution includes sulfuric acid; however, other oradditional acids can be used. In one non-limiting polishing solution,the polishing solution can include by volume 60-95% sulfuric acid and5-40% de-ionized water (DI water). Typically, the polishing solutionthat includes an acid will increase in temperature during the making ofthe solution and/or during the polishing procedure. As such, thepolishing solution is typically stirred and/or cooled during making ofthe solution and/or during the polishing procedure. The temperature ofthe polishing solution is typically about 20-100° C., and typicallygreater than about 25° C. One non-limiting polishing technique that canbe used is an electro-polishing technique. When an electro-polishingtechnique is used, a voltage of about 2-30V, and typically about 5-12Vis applied to the blank, rod, tube, etc. during the polishing process;however, it will be appreciated that other voltages can be used. Thetime used to polish the metal alloy is dependent on both the size of theblank, rod, tube, etc. and the amount of material that needs to beremoved from the blank, rod, tube, etc. The blank, rod, tube, etc. canbe processed by use of a two-step polishing process wherein the metalalloy piece is at least partially immersed in the polishing solution fora given period (e.g., 0.1-15 minutes, etc.), rinsed (e.g., DI water,etc.) for a short period of time (e.g., 0.02-1 minute, etc.), and thenflipped over and at least partially immersed in the solution again forthe same or similar duration as the first time; however, this is notrequired. The metal alloy can be rinsed (e.g., DI water, etc.) for aperiod of time (e.g., 0.01-5 minutes, etc.) before rinsing with asolvent (e.g., acetone, methyl alcohol, etc.); however, this is notrequired. The metal alloy can be dried (e.g., exposure to theatmosphere, maintained in an inert gas environment, etc.) on a cleansurface. These polishing procedures can be repeated until the desiredamount of polishing of the blank, rod, tube, etc. is achieved. Theblank, rod, tube, etc. can be uniformly electropolished or selectivelyelectropolished. When the blank, rod, tube, etc. is selectivelyelectropolished, the selective electropolishing can be used to obtaindifferent surface characteristics of the blank, rod, tube, etc. and/orselectively expose one or more regions of the blank, rod, tube, etc.;however, this is not required.

In still yet a further and/or alternative non-limiting aspect of thepresent invention, the blank, rod, tube, etc. can be resized to thedesired dimension of the medical device. In one non-limiting embodiment,the cross-sectional area or diameter of the blank, rod, tube, etc. isreduced to a final blank, rod, tube, etc. dimension in a single step orby a series of steps. The reduction of the outer cross-sectional area ordiameter of the blank, rod, tube, etc. may be obtained by centerlessgrinding, turning, electropolishing, drawing process, grinding, lasercutting, shaving, polishing, EDM cutting, etc. The outer cross-sectionalarea or diameter size of the blank, rod, tube, etc. can be reduced bythe use of one or more drawing processes; however, this is not required.During the drawing process, care should be taken to not formmicro-cracks in the blank, rod, tube, etc. during the reduction of theblank, rod, tube, etc. outer cross-sectional area or diameter.Generally, the blank, rod, tube, etc. should not be reduced incross-sectional area by more about 25% each time the blank, rod, tube,etc. is drawn through a reducing mechanism (e.g., a die, etc.). In onenon-limiting process step, the blank, rod, tube, etc. is reduced incross-sectional area by about 0.1-20% each time the blank, rod, tube,etc. is drawn through a reducing mechanism. In another and/oralternative non-limiting process step, the blank, rod, tube, etc. isreduced in cross-sectional area by about 1-15% each time the blank, rod,tube, etc. is drawn through a reducing mechanism. In still anotherand/or alternative non-limiting process step, the blank, rod, tube, etc.is reduced in cross-sectional area by about 2-15% each time the blank,rod, tube, etc. is drawn through a reducing mechanism. In yet anotherone non-limiting process step, the blank, rod, tube, etc. is reduced incross-sectional area by about 510% each time the blank, rod, tube, etc.is drawn through a reducing mechanism. In another and/or alternativenon-limiting embodiment of the invention, the blank, rod, tube, etc. ofmetal alloy is drawn through a die to reduce the cross-sectional area ofthe blank, rod, tube, etc. Generally, before drawing the blank, rod,tube, etc. through a die, one end of the blank, rod, tube, etc. isnarrowed down (nosed) so as to allow it to be fed through the die;however, this is not required. The tube drawing process is typically acold drawing process or a plug drawing process through a die. When acold drawing or mandrel drawing process is used, a lubricant (e.g.,molybdenum paste, grease, etc.) is typically coated on the outer surfaceof the blank, rod, tube, etc. and the blank, rod, tube, etc. is thendrawn though the die. Typically, little or no heat is used during thecold drawing process. After the blank, rod, tube, etc. has been drawnthrough the die, the outer surface of the blank, rod, tube, etc. istypically cleaned with a solvent to remove the lubricant so as to limitthe amount of impurities that are incorporated in the metal alloy;however, this is not required. This cold drawing process can be repeatedseveral times until the desired outer cross-sectional area or diameter,inner cross-sectional area or diameter and/or wall thickness of theblank, rod, tube, etc. is achieved. A plug drawing process can also oralternatively be used to size the blank, rod, tube, etc. The plugdrawing process typically does not use a lubricant during the drawingprocess. The plug drawing process typically includes a heating step toheat the blank, rod, tube, etc. prior and/or during the drawing of theblank, rod, tube, etc. through the die. The elimination of the use of alubricant can reduce the incidence of impurities being introduced intothe metal alloy during the drawing process. During the plug drawingprocess, the blank, rod, tube, etc. can be protected from oxygen by useof a vacuum environment, a non-oxygen environment (e.g., hydrogen, argonand hydrogen mixture, nitrogen, nitrogen and hydrogen, etc.) or an inertenvironment. One non-limiting protective environment includes argon,hydrogen or argon and hydrogen; however, other or additional inertgasses can be used. As indicated above, the blank, rod, tube, etc. istypically cleaned after each drawing process to remove impurities and/orother undesired materials from the surface of the blank, rod, tube,etc.; however, this is not required. Typically, the blank, rod, tube,etc. should be shielded from oxygen and nitrogen when the temperature ofthe blank, rod, tube, etc. is increased to above 500° C., and typicallyabove 450° C., and more typically above 400° C.; however, this is notrequired. When the blank, rod, tube, etc. is heated to temperaturesabove about 400-500° C., the blank, rod, tube, etc. has a tendency tobegin form nitrides and/or oxides in the presence of nitrogen andoxygen. In these higher temperature environments, a hydrogenenvironment, argon and hydrogen environment, etc. is generally used.When the blank, rod, tube, etc. is drawn at temperatures below 400-500°C., the blank, rod, tube, etc. can be exposed to air with little or noadverse effects; however, an inert or slightly reducing environment isgenerally more desirable.

In still a further and/or alternative non-limiting aspect of the presentinvention, the blank, rod, tube, etc. during the drawing process can benitride; however, this is not required. The nitride layer on the blank,rod, tube, etc. can function as a lubricating surface during the drawingprocess to facilitate in the drawing of the blank, rod, tube, etc. Theblank, rod, tube, etc. is generally nitrided in the presence of nitrogenor a nitrogen mixture (e.g., 97% N-3% H, etc.) for at least about oneminute at a temperature of at least about 400° C. In one-limitingnitriding process, the blank, rod, tube, etc. is heated in the presenceof nitrogen or a nitrogen-hydrogen mixture to a temperature of about400-800° C. for about 1-30 minutes. In one non-limiting embodiment ofthe invention, the surface of the blank, rod, tube, etc. is nitridedprior to at least one drawing step for the blank, rod, tube, etc. In onenon-limiting aspect of this embodiment, the surface of the blank, rod,tube, etc. is nitrided prior to a plurality of drawing steps. In anothernon-limiting aspect of this invention, after the blank, rod, tube, etc.has been annealed, the blank, rod, tube, etc. is nitrided prior to beingdrawn. In another and/or alternative non-limiting embodiment, the blank,rod, tube, etc. is cleaned to remove nitride compounds on the surface ofthe blank, rod, tube, etc. prior to annealing the rod to tube. Thenitride compounds can be removed by a variety of steps such as, but notlimited to, grit blasting, polishing, etc. After the blank, rod, tube,etc. has been annealed, the blank, rod, tube, etc. can be nitrided againprior to one or more drawing steps; however, this is not required. Ascan be appreciated, the complete outer surface of the blank, rod, tube,etc. can be nitrided or a portion of the outer surface of the blank,rod, tube, etc. can be nitrided. Nitriding only selected portions of theouter surface of the blank, rod, tube, etc. can be used to obtaindifferent surface characteristics of the blank, rod, tube, etc.;however, this is not required.

In yet a further and/or alternative non-limiting aspect of the presentinvention, the blank, rod, tube, etc. is cooled after being annealed;however, this is not required. Generally, the blank, rod, tube, etc. iscooled at a fairly quick rate after being annealed so as to inhibit orprevent the formation of a sigma phase in the metal alloy; however, thisis not required. Generally, the blank, rod, tube, etc. is cooled at arate of at least about 50° C. per minute after being annealed, typicallyat least about 100° C. per minute after being annealed, more typicallyabout 75°−500° C. per minute after being annealed, even more typicallyabout 100°−400° C. per minute after being annealed, still even moretypically about 150-350° C. per minute after being annealed, and yetstill more typically about 200-300° C. per minute after being annealed,and still yet even more typically about 250-280° C. per minute afterbeing annealed; however, this is not required.

In still yet a further and/or alternative non-limiting aspect of thepresent invention, the blank, rod, tube, etc. is annealed after one ormore drawing processes. The metal alloy blank, rod, tube, etc. can beannealed after each drawing process or after a plurality of drawingprocesses. The metal alloy blank, rod, tube, etc. is typically annealedprior to about a 60% cross-sectional area size reduction of the metalalloy blank, rod, tube, etc. In other words, the blank, rod, tube, etc.should not be reduced in cross-sectional area by more than 60% beforebeing annealed. A too large of a reduction in the cross-sectional areaof the metal alloy blank, rod, tube, etc. during the drawing processprior to the blank, rod, tube, etc. being annealed can result inmicro-cracking of the blank, rod, tube, etc. In one non-limitingprocessing step, the metal alloy blank, rod, tube, etc. is annealedprior to about a 50% cross-sectional area size reduction of the metalalloy blank, rod, tube, etc. In another and/or alternative non-limitingprocessing step, the metal alloy blank, rod, tube, etc. is annealedprior to about a 45% cross-sectional area size reduction of the metalalloy blank, rod, tube, etc. In still another and/or alternativenon-limiting processing step, the metal alloy blank, rod, tube, etc. isannealed prior to about a 1-45% cross-sectional area size reduction ofthe metal alloy blank, rod, tube, etc. In yet another and/or alternativenon-limiting processing step, the metal alloy blank, rod, tube, etc. isannealed prior to about a 5-30% cross-sectional area size reduction ofthe metal alloy blank, rod, tube, etc. In still yet another and/oralternative non-limiting processing step, the metal alloy blank, rod,tube, etc. is annealed prior to about a 5-15% cross-sectional area sizereduction of the metal alloy blank, rod, tube, etc. When the blank, rod,tube, etc. is annealed, the blank, rod, tube, etc. is typically heatedto a temperature of about 800-1700° C. for a period of about 2-200minutes; however, other temperatures and/or times can be used. In onenon-limiting processing step, the metal alloy blank, rod, tube, etc. isannealed at a temperature of about 1000-1600° C. for about 2-100minutes. In another non-limiting processing step, the metal alloy blank,rod, tube, etc. is annealed at a temperature of about 1100-1500° C. forabout 5-30 minutes. The annealing process typically occurs in an inertenvironment or an oxygen reducing environment so as to limit the amountof impurities that may embed themselves in the metal alloy during theannealing process. One non-limiting oxygen reducing environment that canbe used during the annealing process is a hydrogen environment; however,it can be appreciated that a vacuum environment can be used or one ormore other or additional gasses can be used to create the oxygenreducing environment. At the annealing temperatures, a hydrogencontaining atmosphere can further reduce the amount of oxygen in theblank, rod, tube, etc. The chamber in which the blank, rod, tube, etc.is annealed should be substantially free of impurities (e.g., carbon,oxygen, and/or nitrogen) so as to limit the amount of impurities thatcan embed themselves in the blank, rod, tube, etc. during the annealingprocess. The annealing chamber typically is formed of a material thatwill not impart impurities to the blank, rod, tube, etc. as the blank,rod, tube, etc. is being annealed. Non-limiting materials that can beused to form the annealing chamber include, but are not limited to,molybdenum, rhenium, tungsten, molybdenum TZM alloy, cobalt, chromium,ceramic, etc. When the blank, rod, tube, etc. is restrained in theannealing chamber, the restraining apparatuses that are used to contactthe metal alloy blank, rod, tube, etc. are typically formed of materialsthat will not introduce impurities to the metal alloy during theprocessing of the blank, rod, tube, etc. Non-limiting examples ofmaterials that can be used to at least partially form the restrainingapparatuses include, but are not limited to, molybdenum, titanium,yttrium, zirconium, rhenium, cobalt, chromium, tantalum, and/ortungsten. In still another and/or alternative non-limiting processingstep, the parameters for annealing can be changed as the blank, rod,tube, etc. as the cross-sectional area or diameter; and/or wallthickness of the blank, rod, tube, etc. are changed. It has been foundthat good grain size characteristics of the tube can be achieved whenthe annealing parameters are varied as the parameters of the blank, rod,tube, etc. change. For example, as the wall thickness is reduced, theannealing temperature is correspondingly reduced; however, the times forannealing can be increased. As can be appreciated, the annealingtemperatures of the blank, rod, tube, etc. can be decreased as the wallthickness decreases, but the annealing times can remain the same or alsobe reduced as the wall thickness reduces. After each annealing process,the grain size of the metal in the blank, rod, tube, etc. should be nogreater than 4 ASTM. Generally, the grain size range is about 4-14 ASTM.Grain sizes of 7-14 ASTM can be achieved by the annealing process of thepresent invention. It is believed that as the annealing temperature isreduced as the wall thickness reduces, small grain sizes can beobtained. The grain size of the metal in the blank, rod, tube, etc.should be as uniform as possible. In addition, the sigma phase of themetal in the blank, rod, tube, etc. should be as reduced as much aspossible. The sigma phase is a spherical, elliptical or tetragonalcrystalline shape in the metal alloy. After the final drawing of theblank, rod, tube, etc., a final annealing of the blank, rod, tube, etc.can be done for final strengthening of the blank, rod, tube, etc.;however, this is not required. This final annealing process, when used,generally occurs at a temperature of about 900°-1600° C. for at leastabout five minutes; however, other temperatures and/or time periods canbe used.

In another and/or alternative non-limiting aspect of the presentinvention, the blank, rod, tube, etc. can be cleaned prior to and/orafter being annealed. The cleaning process is designed to removeimpurities, lubricants (e.g., nitride compounds, molybdenum paste,grease, etc.) and/or other materials from the surfaces of the blank,rod, tube, etc. Impurities that are on one or more surfaces of theblank, rod, tube, etc. can become permanently embedded into the blank,rod, tube, etc. during the annealing processes. These imbeddedimpurities can adversely affect the physical properties of the metalalloy as the blank, rod, tube, etc. is formed into a medical device,and/or can adversely affect the operation and/or life of the medicaldevice. In one non-limiting embodiment of the invention, the cleaningprocess includes a delubrication or degreasing process which istypically followed by a pickling process; however, this is not required.The delubrication or degreasing process followed by a pickling processare typically used when a lubricant has been used on the blank, rod,tube, etc. during a drawing process. Lubricants commonly include carboncompounds, nitride compounds, molybdenum paste, and other types ofcompounds that can adversely affect the metal alloy if such compoundsand/or elements in such compounds become associated and/or embedded withthe metal alloy during an annealing process. The delubrication ordegreasing process can be accomplished by a variety of techniques suchas, but not limited to, 1) using a solvent (e.g., acetone, methylalcohol, etc.) and wiping the metal alloy with a Kimwipe or otherappropriate towel, 2) by at least partially dipping or immersing themetal alloy in a solvent and then ultrasonically cleaning the metalalloy, 3) sand blasting the metal alloy, and/or 4) chemical etching themetal alloy. As can be appreciated, the metal alloy can be delubricatedor degreased in other or additional ways. After the metal alloy blank,rod, tube, etc. has been delubricated or degreased, the blank, rod,tube, etc. can be further cleaned by use of a pickling process; however,this is not required. The pickling process, when used, includes the useof one or more acids to remove impurities from the surface of the blank,rod, tube, etc. Non-limiting examples of acids that can be used as thepickling solution include, but are not limited to, nitric acid, aceticacid, sulfuric acid, hydrochloric acid, and/or hydrofluoric acid. Theseacids are typically analytical reagent (ACS) grade acids. The acidsolution and acid concentration are selected to remove oxides and otherimpurities on the blank, rod, tube, etc. surface without damaging orover etching the surface of the blank, rod, tube, etc. A blank, rod,tube, etc. surface that includes a large amount of oxides and/ornitrides typically requires a stronger pickling solution and/or longpickling process times. Non-limiting examples of pickling solutionsinclude 1) 25-60% DI water, 30-60% nitric acid, and 2-20% sulfuric acid;2) 40-75% acetic acid, 10-35% nitric acid, and 1-12% hydrofluoric acid;and 3) 50-100% hydrochloric acid. As can be appreciated, one or moredifferent pickling solutions can be used during the pickling process.During the pickling process, the blank, rod, tube, etc. is fully orpartially immersed in the pickling solution for a sufficient amount oftime to remove the impurities from the surface of the blank, rod, tube,etc. Typically, the time period for pickling is about 2-120 seconds;however, other time periods can be used. After the blank, rod, tube,etc. has been pickled, the blank, rod, tube, etc. is typically rinsedwith a water (e.g., DI water, etc.) and/or a solvent (e.g., acetone,methyl alcohol, etc.) to remove any pickling solution from the blank,rod, tube, etc. and then the blank, rod, tube, etc. is allowed to dry.The blank, rod, tube, etc. can be keep in a protective environmentduring the rinse and/or drying process to inhibit or prevent oxides fromreforming on the surface of the blank, rod, tube, etc. prior to theblank, rod, tube, etc. being drawn and/or annealed; however, this is notrequired.

In yet another and/or alternative non-limiting aspect of the presentinvention, the restraining apparatuses that are used to contact themetal alloy blank, rod, tube, etc. during an annealing process and/ordrawing process are typically formed of materials that will notintroduce impurities to the metal alloy during the processing of theblank, rod, tube, etc. In one non-limiting embodiment, when the metalalloy blank, rod, tube, etc. is exposed to temperatures above 150° C.,the materials that contact the metal alloy blank, rod, tube, etc. duringthe processing of the blank, rod, tube, etc. are typically made fromchromium, cobalt, molybdenum, rhenium, tantalum and/or tungsten;however, other metals can be used. When the metal alloy blank, rod,tube, etc. is processed at lower temperatures (i.e., 150° C. or less),materials made from Teflon® parts can also or alternatively be used.

In still another and/or alternative non-limiting aspect of the presentinvention, after the metal alloy blank, rod, tube, etc., has been formedto the desired shape, the outer cross-sectional area or diameter, innercross-sectional area or diameter and/or wall thickness, can be cutand/or etched to at least partially form the desired configuration ofthe medical device (e.g., stent, pedicle screw, PFO device, valve,spinal implant, vascular implant, graft, guide wire, sheath, stentcatheter, electrophysiology catheter, hypotube, catheter, staple,cutting device, dental implant, bone implant, prosthetic implant ordevice to repair, replace and/or support a bone and/or cartilage, nail,rod, screw, post, cage, plate, cap, hinge, joint system, wire, anchor,spacer, shaft, anchor, disk, ball, tension band, locking connector, orother structural assembly that is used in a body to support a structure,mount a structure and/or repair a structure in a body, etc.). The blank,rod, tube, etc. can be cut or otherwise formed by one or more processes(e.g., centerless grinding, turning, electropolishing, drawing process,grinding, laser cutting, shaving, polishing, EDM cutting, etching,micro-machining, laser micro-machining, micro-molding, machining, etc.).In one non limiting embodiment of the invention, the metal alloy blank,rod, tube, etc. is at least partially cut by a laser. The laser istypically desired to have a beam strength which can heat the metal alloyblank, rod, tube, etc. to a temperature of at least about 2200-2300° C.In one non-limiting aspect of this embodiment, a pulsed Nd:YAGneodymium-doped yttrium aluminum garnet (Nd:Y3Al5O12) or CO2 laser isused to at least partially cut a pattern of medical device out of themetal alloy blank, rod, tube, etc. In another and/or alternativenon-limiting aspect of this embodiment, the cutting of the metal alloyblank, rod, tube, etc. by the laser can occur in a vacuum environment,an oxygen reducing environment, or an inert environment; however, thisis not required. It has been found that laser cutting of the blank, rod,tube, etc. in a non-protected environment can result in impurities beingintroduced into the cut blank, rod, tube, etc.; such introducedimpurities can induce micro-cracking of the blank, rod, tube, etc.during the cutting of the blank, rod, tube, etc. One non-limiting oxygenreducing environment includes a combination of argon and hydrogen;however, a vacuum environment, an inert environment, or other oradditional gasses can be used to form the oxygen reducing environment.In still another and/or alternative non-limiting aspect of thisembodiment, the metal alloy blank, rod, tube, etc. is stabilized so asto limit or prevent vibration of the blank, rod, tube, etc. during thecutting process. The apparatus used to stabilize the blank, rod, tube,etc. can be formed of molybdenum, rhenium, tungsten, tantalum, cobalt,chromium, molybdenum TZM alloy, ceramic, etc. so as to not introducecontaminants to the blank, rod, tube, etc. during the cutting process;however, this is not required. Vibrations in the blank, rod, tube, etc.during the cutting of the blank, rod, tube, etc. can result in theformation of micro-cracks in the blank, rod, tube, etc. as the blank,rod, tube, etc. is cut. The average amplitude of vibration during thecutting of the blank, rod, tube, etc. is generally no more than about150% the wall thickness of the blank, rod, tube, etc.; however, this isnot required. In one non-limiting aspect of this embodiment, the averageamplitude of vibration is no more than about 100% the wall thickness ofthe blank, rod, tube, etc. In another non-limiting aspect of thisembodiment, the average amplitude of vibration is no more than about 75%the wall thickness of the blank, rod, tube, etc. In still anothernon-limiting aspect of this embodiment, the average amplitude ofvibration is no more than about 50% the wall thickness of the blank,rod, tube, etc. In yet another non-limiting aspect of this embodiment,the average amplitude of vibration is no more than about 25% the wallthickness of the blank, rod, tube, etc. In still yet anothernon-limiting aspect of this embodiment, the average amplitude ofvibration is no more than about 15% the wall thickness of the blank,rod, tube, etc.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the metal alloy blank, rod, tube, etc., after beingformed to the desired medical device, can be cleaned, polished,sterilized, nitrided, etc. for final processing of the medical device.In one non-limiting embodiment of the invention, the medical device iselectropolished. In one non-limiting aspect of this embodiment, themedical device is cleaned prior to being exposed to the polishingsolution; however, this is not required. The cleaning process (whenused) can be accomplished by a variety of techniques such as, but notlimited to, 1) using a solvent (e.g., acetone, methyl alcohol, etc.) andwiping the medical device with a Kimwipe or other appropriate towel,and/or 2) by at least partially dipping or immersing the medical devicein a solvent and then ultrasonically cleaning the medical device. As canbe appreciated, the medical device can be cleaned in other or additionalways. In another and/or alternative non-limiting aspect of thisembodiment, the polishing solution can include one or more acids. Onenon-limiting formulation of the polishing solution includes about 10-80percent by volume sulfuric acid. As can be appreciated, other polishingsolution compositions can be used. In still another and/or alternativenon-limiting aspect of this embodiment, about 5-12 volts are directed tothe medical device during the electropolishing process; however, othervoltage levels can be used. In yet another and/or alternativenon-limiting aspect of this embodiment, the medical device is rinsedwith water and/or a solvent and allowed to dry to remove polishingsolution on the medical device.

The use of the novel alloy to form all or a portion of the medicaldevice can result in several advantages over medical devices formed fromother materials. These advantages include, but are not limited to:

The novel alloy has increased strength as compared with stainless steelor chromium-cobalt alloys, thus less quantity of novel alloy can be usedin the medical device to achieve similar strengths as compared tomedical devices formed of different metals. As such, the resultingmedical device can be made smaller and less bulky by use of the novelalloy without sacrificing the strength and durability of the medicaldevice. The medical device can also have a smaller profile, thus can beinserted into smaller areas, openings and/or passageways. The increasedstrength of the novel alloy also results in the increased radialstrength of the medical device. For example, the thickness of the wallsof the medical device and/or the wires used to form the medical devicecan be made thinner and achieve a similar or improved radial strength ascompared with thicker walled medical devices formed of stainless steelor cobalt and chromium alloy.

The novel alloy has improved stress-strain properties, bendabilityproperties, elongation properties and/or flexibility properties of themedical device as compared with stainless steel or chromium-cobaltalloys, thus resulting in an increased life for the medical device. Forinstance, the medical device can be used in regions that subject themedical device to repeated bending. Due to the improved physicalproperties of the medical device from the novel alloy, the medicaldevice has improved resistance to fracturing in such frequent bendingenvironments. These improved physical properties at least in part resultfrom the composition of the novel alloy; the grain size of the novelalloy; the carbon, oxygen and nitrogen content of the novel alloy;and/or the carbon/oxygen ratio of the novel alloy.

The novel alloy has a reduced degree of recoil during the crimpingand/or expansion of the medical device as compared with stainless steelor chromium-cobalt alloys. The medical device formed of the novel alloybetter maintains its crimped form and/or better maintains its expandedform after expansion due to the use of the novel alloy. As such, whenthe medical device is to be mounted onto a delivery device when themedical device is crimped, the medical device better maintains itssmaller profile during the insertion of the medical device in a bodypassageway. Also, the medical device better maintains its expandedprofile after expansion so as to facilitate in the success of themedical device in the treatment area.

The novel alloy has improved radiopaque properties as compared tostandard materials such as stainless steel or cobalt-chromium alloy,thus reducing or eliminating the need for using marker materials on themedical device. For example, the novel alloy is at least about 10-20%more radiopaque than stainless steel or cobalt-chromium alloy.

The novel alloy is less of an irritant to the body than stainless steelor cobalt-chromium alloy, thus can result in reduced inflammation,faster healing, and/or increased success rates of the medical device.When the medical device is expanded in a body passageway, some minordamage to the interior of the passageway can occur. When the body beginsto heal such minor damage, the body has less adverse reaction to thepresence of the novel alloy than compared to other metals such asstainless steel or cobalt-chromium alloy.

One non-limiting object of the present invention is the provision of amedical device that is at least partially formed of a novel alloy.

Another and/or alternative non-limiting object of the present inventionis the provision of a medical device having improved procedural successrates.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a method and process for forming a metalalloy that inhibits or prevents the formation of micro-cracks during theprocessing of the alloy into a medical device.

Still another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is formed of amaterial that improves the physical properties of the medical device.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is at leastpartially formed of a novel alloy that has increased strength and canalso be used as a marker material.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that at least partiallyincludes a novel alloy that enables the medical device to be formed withless material without sacrificing the strength of the medical device ascompared to prior medical devices.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is simple and costeffective to manufacture.

A further and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is at leastpartially coated with one or more polymer coatings.

Still a further and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is coated with oneor more biological agents.

Yet a further and/or alternative non-limiting object of the presentinvention is the provision of a medical device that has one or morepolymer coatings to at least partially control the release rate of oneor more biological agents.

Still yet a further and/or alternative non-limiting object of thepresent invention is the provision of a medical device that includes oneor more surface structures and/or micro-structures.

Still a further and/or alternative non-limiting object of the presentinvention is the provision of a method and process for forming a novelalloy into a medical device.

Another and/or alternative non-limiting object of the present inventionis the provision of a medical device that includes one or more surfacestructures, micro-structures and/or internal structures, and aprotective coating that at least partially covers and/or protects suchstructures.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes one or moremarkers.

Still another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes and/or isused with one or more physical hindrances.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that can be used inconjunction with one or more biological agents not on or in the medicaldevice.

A further and/or alternative non-limiting object of the presentinvention is the provision of a method and process for forming a novelalloy that inhibits or prevents the formation of micro-cracks during theprocessing of the alloy into a medical device.

Still a further and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes CNT.

Another and/or alternative non-limiting object of the present inventionis the provision of a method and process for forming a novel alloy thatinhibits or prevents in the introduction of impurities into the alloyduring the processing of the alloy into a medical device.

Still another and/or alternative non-limiting object of the presentinvention is the provision of a method and process for forming a novelalloy that inhibits or prevents crack propagation and/or fatiguefailure.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is used inorthopedics (e.g., orthopedic device, nail, rod, screw, post, cage,plate, pedicle screw, cap, hinge, joint system, wire, anchor, spacer,shaft, spinal implant, anchor, disk, ball, tension band, lockingconnector, bone implant, prosthetic implant or device to repair, replaceand/or support a bone; etc.), which medical device may or may not beexpandable.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is in the form of animplant for insertion into a body passageway (e.g., PFO device, stent,valve, spinal implant, vascular implant; graft, guide wire, sheath,stent catheter, electrophysiology catheter, hypotube, catheter, etc.),which medical device may or may not be expandable.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that is used in dentistryand orthodontics (e.g., dental restorations, dental implants, crowns,bridges, braces, dentures, wire, anchors, spacers, retainers, tubes,pins, screws, posts, rods, plates, palatal expander, orthodonticheadgear, orthodontic archwire, teeth aligners, quadhelix, etc.). Onenon-limiting medical device that is used in dentistry and orthodonticsis in the form of a dental implant. The dental implant for insertioninto bone generally includes an implant anchor having a connectionarrangement (e.g., an interlocking thread, etc.). The dental implant caninclude a plurality of keys disposed about the distal end of theabutment, which distal end is capable of being affixed to the prosthetictooth or dental appliance, and has an implantable anchor having aproximal and distal end, a plurality of female keyways defined into theproximal end of the anchor, the keyways capable of coupling to the malekeys of the abutment and thereby preventing relative rotation of theabutment and anchor; however, this is not required. The dental implantcan optionally include a repository bore perpendicular to thelongitudinal bore defined in a distal portion of the anchor. Therepository bore is cut through a portion of the anchor creating verysharp cutting edges to become self-tapping. The repository bore also canoptionally serve as a repository for the bone chips created during thethread cutting process. One non-limiting dental implant is described inU.S. Pat. No. 7,198,488, which is incorporated herein by reference. Thedental implant has a cylindrical anchoring head formed unitarily with ascrew element. The screw element, usually made of the metal alloy of thepresent invention or titanium with a roughened surface, is to be screwedinto the recipient jaw bone. The anchoring head which can be formed ofthe metal alloy of the present invention is adapted to have a prosthetictooth mounted on it.

A further and/or alternative non-limiting object of the presentinvention is the provision of a method and process for forming a novelmetal alloy that inhibits or prevents the introduction of impuritiesinto the alloy during the processing of the alloy into a medical device.

Another and/or alternative non-limiting object of the present inventionis the provision of a method and process of forming a medical devicethat includes a swaging process to harden the outer surface of themedical device.

Still another and/or alternative non-limiting object of the presentinvention is the provision of a method and process of forming a medicaldevice that that includes a swaging process to form compounds of ReB2,ReN2 and/or ReN3 on the surface of the medical device.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a method and process of forming a medicaldevice that includes a swaging process to form a medical device having ahard surface and a softer core.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a method and process of forming a medicaldevice that includes one metal or metal alloy coated with another metalor metal alloy and wherein the outer coating of the metal or metal alloyhas a hardness at room temperature that is greater than the hardness ofthe coated metal or metal alloy.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a method and process of forming a medicaldevice that includes one metal or metal alloy coated with another metalor metal alloy and wherein the outer coating of the metal or metal alloyhas a melting point that is less than the melting point of the coatedmetal or metal alloy.

These and other advantages will become apparent to those skilled in theart upon the reading and following of this description.

Other or additional features of the invention are disclosed in U.S. Pat.Nos. 7,488,444; 7,452,502; 7,540,994; 7,452,501; 8,398,916; U.S.application Ser. Nos. 12/373,380; 61/816,357; 61/959,260; 61/871,902;61/881,499; and PCT Application Nos. PCT/US2013/045543 andPCT/US2013/062804, which are all incorporated by reference herein.

It will thus be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained, andsince certain changes may be made in the constructions set forth withoutdeparting from the spirit and scope of the invention, it is intendedthat all matter contained in the above description and shown in theaccompanying drawings shall be interpreted as illustrative and not in alimiting sense. The invention has been described with reference topreferred and alternate embodiments. Modifications and alterations willbecome apparent to those skilled in the art upon reading andunderstanding the detailed discussion of the invention provided herein.This invention is intended to include all such modifications andalterations insofar as they come within the scope of the presentinvention. It is also to be understood that the following claims areintended to cover all of the generic and specific features of theinvention herein described and all statements of the scope of theinvention, which, as a matter of language, might be said to falltherebetween.

1-30. (canceled)
 31. A method for forming a spinal rod that includes ametal coated rod comprising the steps of: a) providing a rod core; saidrod core is formed of a metal alloy that includes at least about 55 wt.% of a solid solution of rhenium and molybdenum alloy; said metal alloyincludes at least about 20 wt. % rhenium and at least about 20 wt. %molybdenum; b) providing a coating material; said coating material isformed of a different material from said metal alloy used to form saidrod core; said coating material is selected from the group consisting ofiron, cobalt-chromium, titanium alloy, stainless steel, rhenium alloy,molybdenum alloy, polymer material, and ceramic material; and c) coatingsaid coating material on at least a portion of an outer surface of saidrod core to formed said metal coated rod; said rod core constitutes atleast 50% of an overall cross-section of said metal coated rod.
 32. Themethod as defined in claim 31, wherein said metal alloy includes 40-60wt. % rhenium and 40-60 wt. % molybdenum.
 33. The method as defined inclaim 31, wherein said content of said rhenium and molybdenum in saidmetal alloy constitutes at least 95 wt. % of said metal alloy; saidmetal alloy includes one or more metals selected from the groupconsisting of copper, manganese, silicon, and titanium.
 34. The methodas defined in claim 32, wherein said content of said rhenium andmolybdenum in said metal alloy constitutes at least 95 wt. % of saidmetal alloy; said metal alloy includes one or more metals selected fromthe group consisting of copper, manganese, silicon, and titanium. 35.The method as defined in claim 31, wherein said coating material isselected from the group consisting of titanium, titanium alloy,cobalt-chromium alloy, and stainless steel.
 36. The method as defined inclaim 34, wherein said coating material is selected from the groupconsisting of titanium, titanium alloy, cobalt-chromium alloy, andstainless steel.
 37. The method as defined in claim 31, wherein said rodcore constitutes at least 90% of an overall cross-section of said metalcoated rod.
 38. The method as defined in claim 36, wherein said rod coreconstitutes at least 90% of an overall cross-section of said metalcoated rod.
 39. The method as defined in claim 31, further including thesteps of: drawing down said outer cross-sectional area of said metalcoated rod by a reducing mechanism; annealing said metal coated rod atan annealing temperature in an oxygen reducing environment or inertenvironment after said rod or tube has been drawn down; and, coolingsaid annealed metal coated rod.
 40. The method as defined in claim 38,further including the steps of: drawing down said outer cross-sectionalarea of said metal coated rod by a reducing mechanism; annealing saidmetal coated rod at an annealing temperature in an oxygen reducingenvironment or inert environment after said rod or tube has been drawndown; and, cooling said annealed metal coated rod.
 41. The method asdefined in claim 31, wherein at least one region of an outer surface ofsaid metal coated rod includes at least one biological agent.
 42. Themethod as defined in claim 38, wherein at least one region of an outersurface of said metal coated rod includes at least one biological agent.43. The method as defined in claim 31, wherein at least one region ofsaid metal coated rod includes at least one polymer; at least one saidpolymer at least partially coats, encapsulates, or combinations thereof,at least one biological agent.
 44. The method as defined in claim 38,wherein at least one region of said metal coated rod includes at leastone polymer; at least one said polymer at least partially coats,encapsulates, or combinations thereof, at least one biological agent.45. A spinal rod that includes a metal coated rod comprising: a) a rodcore; said rod core is formed of a metal alloy that includes at leastabout 55 wt. % of a solid solution of rhenium and molybdenum alloy; saidmetal alloy includes at least about 20 wt. % rhenium and at least about20 wt. % molybdenum; and b) a coating material; said coating material isformed of a different material from said metal alloy used to form saidrod core; said coating material is selected from form the groupconsisting of iron, cobalt-chromium, titanium alloy, stainless steel,rhenium alloy, molybdenum alloy, polymer material, and ceramic material;and wherein said coating material is coated on at least a portion of anouter surface of said rod core to formed said metal coated rod; andwherein said rod core constitutes at least 50% of an overallcross-section of said metal coated rod.
 46. The spinal rod as defined inclaim 45, wherein said metal alloy includes 40-60 wt. % rhenium, 40-60wt. % molybdenum.
 47. The spinal rod as defined in claim 45, whereinsaid a content of said rhenium and molybdenum in said metal alloyconstitutes at least 95 wt. % of said metal alloy; said metal alloyincludes one or more metals selected from the group consisting ofcopper, manganese, silicon, and titanium.
 48. The spinal rod as definedin claim 46, wherein a content of said rhenium and molybdenum in saidmetal alloy constitutes at least 95 wt. % of said metal alloy; saidmetal alloy includes one or more metals selected from the groupconsisting of copper, manganese, silicon, and titanium.
 49. The spinalrod as defined in claim 45, wherein said coating material is selectedfrom the group consisting of titanium, titanium alloy, cobalt-chromiumalloy, and stainless steel.
 50. The spinal rod as defined in claim 48,wherein said coating material is selected from the group consisting oftitanium, titanium alloy, cobalt-chromium alloy, and stainless steel.51. The spinal rod as defined in claim 45, wherein said rod coreconstitutes at least 90% of an overall cross-section of said metalcoated rod.
 52. The spinal rod as defined in claim 50, wherein said rodcore constitutes at least 90% of an overall cross-section of said metalcoated rod.
 53. The spinal rod as defined in claim 45, wherein at leastone region of an outer surface of said metal coated rod includes atleast one biological agent.
 54. The spinal rod as defined in claim 52,wherein at least one region of an outer surface of said metal coated rodincludes at least one biological agent.
 55. The spinal rod as defined inclaim 45, wherein at least one region of said metal coated rod includesat least one polymer; at least one said polymer at least partiallycoats, encapsulates, or combinations thereof, at least one biologicalagent.
 56. The spinal rod as defined in claim 52, wherein at least oneregion of said metal coated rod includes at least one polymer; at leastone said polymer at least partially coats, encapsulates, or combinationsthereof, at least one biological agent.
 57. A spinal rod that includes ametal coated rod comprising: a) a rod core; said rod core is formed of ametal alloy that includes at least about 80 wt. % of a solid solution ofrhenium and one or more metals selected from the group consisting ofmolybdenum, calcium, chromium, cobalt, copper, gold, hafnium, iron,lead, magnesium, nickel, niobium, osmium, platinum, rare earth metals,rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium,yttrium, zinc, and zirconium; said metal alloy includes at least about20 wt. % rhenium; and b) a coating material; said coating material isformed of a different material from said metal alloy used to form saidrod core; said coating material includes titanium and/or stainlesssteel; and wherein said coating material is coated on at least a portionof an outer surface of said rod core to formed said metal coated rod;and wherein said rod core constitutes at least 50% of an overallcross-section of said metal coated rod.